MEDICAL DEVICES ACT (ZMedPri)

I. GENERAL PROVISIONS
Article 1
(Scope of application)
(1) This Act stipulates:
- medical devices and their accessories for human use,
– conditions and measures for assuring the quality, safety and efficacy of medical devices,
– conditions and procedures for assessing conformity of medical devices,
- labelling and conditions for affixing the CE mark,
- conditions for manufacturing and marketing medical devices,
– conditions and procedures for clinical trials of medical devices,
- monitoring complications related to medical devices,
- tasks and competencies of the notified body,
– tasks and competencies of the notified body, competent for medical devices,
- supervision over the implementation of this Act for the purpose of protecting public health.
(2) The purpose of this Act is to transpose into the legislation of the Republic of Slovenia the contents of the following directives and to regulate issues concerning the implementation of the following decisions and regulations:
– Council Directive 20/1990/EEC on the approximation of the laws of the Member States relating to active implantable medical devices (OJ L no. 189 of 20 July 1990, p. 17), last amended with Directive 2007/47/EC of the European Parliament and Council of 5 September 2007 amending the Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ L no. 247 of 21 September 2007, p. 21), (hereinafter: Directive 90/385/EEC);
– Council Directive 93/42/EEC of 14 June 1993 on medical devices (OJ L no. 169 of 12 July 1993, p. 1), last amended with Directive 2007/47/EC of the European Parliament and Council of 5 September 2007 amending the Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market (OJ L no. 247 of 21 September 2007, p. 21), (hereinafter: Directive 93/42/EEC);
– Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (OJ L 331, 7 December 1998 p. 1), last amended with the Regulation (EC) no. 596/2009 of the European Parliament and of the Council of 18 June 2009, adapting a number of instruments subject to the procedure referred to in Article 251 of the Treaty to Council Decision 1999/468/EC with regard to the regulatory procedure with scrutiny (OJ L 188, 18 July 2009 p. 14), (hereinafter: Directive 98/79/EC);
– Commission Decision of 7 May 2002 on common technical specifications for in vitro-diagnostic medical devices (OJ L 131, 16 May 2002 p. 17), last amended by Commission Decision of 3 February 2009 amending the Commission Decision 2002/364 on common technical specifications for in vitro-diagnostic medical devices (OJ L 39, 10 February 2009 p. 34), (hereinafter: Decision 2002/364/EC);
– Directive 1882/2003/EC of the European Parliament and of the Council of 29 September 2003 adapting to Council Decision 1999/468/EC the provisions relating to committees which assist the Commission in the exercise of its implementing powers laid down in instruments subject to the procedure referred to in Article 251 of the EC Treaty (OJ L 284, 31 October 2003 p. 1), last amended with the Regulation (EC, EURATOM) no. 1101/2008 of the European Parliament and of the Council of 22 October 2008, on the transmission of data subject to statistical confidentiality to the Statistical Office of the European Communities (OJ L 304, 14 November 2008 p. 70), (hereinafter: Regulation 1882/2003/EC);
– Regulation (EC) No 1394/2007 of the European Parliament and of the Council of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2004 (OJ L 324 of 10 December 2007, p. 121).
(3) The terms and conditions of exercising the rights of users to medical devices, prescription, their financing and other issues related to medical devices for rehabilitation, are regulated by the provision on social security.
 

Article 2
(Exceptions to the application of this Act)
The provisions of this Act shall not apply to the following:
1. Medicinal products regulated by the provisions on medicinal products;
2. Cosmetic products regulated by the provisions on cosmetic products;
3. Human blood, products made from human blood, human plasma or blood cells of human origin regulated by the provisions on blood supply, with the exception of those regulated by the fifth paragraph of Article 15 hereof;
4. Organs of human origin for transplantation, regulated by the provisions on separation and transplantation of parts of human body, with the exception of those regulated by the fifth paragraph of Article 15 hereof;
5. Tissues and cells of human origin and products containing tissues and cells of human origin or produced from them, which are regulated by the provisions on the quality and safety of tissues and cells of human origin, intended for treatment;
6. Transplants or tissues or cells of animal origin, unless a device is manufactured utilizing non-viable animal tissue or non-viable products derived from animal tissue;
7. Products using the combination of medicinal product and medical device containing viable cells or tissues or non-viable cells or tissues, with the tissues or cells having the primary effect on the human body and being regulated in accordance with the provisions of the European Union on advanced therapy medicinal products;
8. In vitro medical devices manufactured and used only within the same health institution and on the premises of their manufacture or used on premises in the immediate vicinity without having been transferred to another legal entity, regulated by the provisions on medical activity;
9. Regulation of the protection of the health of workers and the general public against the dangers arising from ionising radiation or on health protection of individuals against the dangers of ionising radiation in relation to medical exposure, regulated by the provisions on protection against ionising radiation and nuclear safety.
 

Article 3
(Medical device)
Medical device means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:
- diagnosis, prevention, monitoring, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap,
- investigation, replacement or modification of the anatomic functions or physiological processes of the organism, or
- control of conception and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such processes.
(2) Accessory to a medical device means an article which whilst not being a medical device is intended specifically by its manufacturer to be used together with a medical device to enable it to be used in accordance with the use of the device intended by the manufacturer of the device;
 

Article 4
(Active medical device)
Active medical device means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity.
 

Article 5
(Active implantable medical device)
(1) Active implantable medical device means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure.
(2) Accessory to active implantable medical device shall be subject to the provisions hereof, regulating active implantable medical devices.
 

Article 6
(In vitro diagnostic medical device)
(1) In vitro diagnostic medical device means any medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information:
- concerning a physiological or pathological state,
- concerning a congenital abnormality,
- to determine the safety and compatibility with potential recipients, or
- to monitor therapeutic measures.
(2) Specimen receptacles classified as in vitro diagnostic medical devices are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
(3) Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.
(4) Accessory to in vitro diagnostic medical device means an article which, whilst not being an in vitro diagnostic medical device, is intended specifically by its manufacturer to be used together with a device to enable that device to be used in accordance with its intended purpose.
(5) Invasive sampling medical device or that which is directly applied to the human body for the purpose of obtaining a specimen shall not be considered to be accessory to in vitro diagnostic medical device.
(6) In vitro diagnostic medical device for self-testing means any device intended by the manufacturer to be able to be used by lay persons in a home environment.
(7) In vitro diagnostic medical device for evaluation of performance of in vitro diagnostic medical device means any device intended by the manufacturer to be subject to one or more performance evaluation studies in laboratories for medical analyses or in other appropriate environments outside their own premises.
 

Article 7
(Medical device manufactured for an individual user)
(1) Medical device manufactured for an individual user is a medical device that is designed with specific characteristics in accordance with a written request of a doctor and intended exclusively for the use of a specific user.
(2) The abovementioned written request may also be made out by any other person authorized by virtue of his professional qualifications to do so.
(3) Medical devices which are manufactured in mass production and must be adjusted so as to meet specific requirements of a doctor or another expert are not medical devices manufactured for an individual user.
 

Article 8
(Medical device or active implantable medical device intended for clinical investigation)
(1) Medical device or active implantable medical device intended for clinical investigation means any medical device intended for use by a specialist doctor when conducting investigations in an adequate human clinical environment.
(2) Any other person qualified for performing clinical investigations based on his professional qualifications shall be deemed to be adequately qualified for performing clinical investigations.
 

Article 9
(Other terms)
For the purposes of this Act, the terms shall have the following meanings:
1. Placing on the market means the first making available in return for payment or free of charge of a medical device on the market of the European Union other than medical devices intended for clinical investigations or performance evaluation of in vitro diagnostic medical devices, regardless of whether it is new or fully refurbished.
2. Putting into service means the stage at which a medical device has been made available to the final user as being ready for use on the European Union market for the first time for its intended purpose. The beginning of the use of an active implantable medical device means making such a device available for performing medical activity.
3. An EC certificate means a document by means of which a notified body guarantees that the manufacturing process or medical device complies with the provisions of the European Union regulating medical devices and the implementing regulations arising from or issued on the basis of this act.
4. Harmonised standard means a standard adopted by one of the bodies for standardisation from Annex I to the Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations (OJ L 204 of 21 July 1998), most recently amended with the Council Directive 2006/96/EC of 20 November 2006 adapting certain Directives in the field of free movement of goods, by reason of the accession of Bulgaria and Romania (OJ L 363 of 20 December 2006, p. 81), (hereinafter: Directive 98/34/EC), based on the proposal drafted by the European Commission in accordance with Article 6 of the Directive 98/34/EC.
5. An EC declaration of conformity means a document by means of which a manufacturer of medical devices guarantees that the manufacturing process or medical device complies with the provisions of the European Union regulating medical devices and the implementing regulations arising from or issued on the basis of this act.
6. Clinical data means data on safety or performance of medical device, obtained on the basis of its use. They are obtained from clinical investigations of this device or clinical investigations or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated, or from published and/or unpublished reports on other clinical experience of either the device in question or a similar device for which equivalence to the device in question can be demonstrated.
7. A single use medical device means a medical device intended to be used only once and for a single patient.
8. Package leaflet means the information for the user attached in written form to the medical device.
9. Recall means any measure aimed at achieving the return of a medical device that does not correspond to the essential requirements of this act and the provisions of the European Union regulating medical devices, which has already been made available to the final user, a legal entity that put it on the market.
10. The CE marking means a mark by means of which a manufacturer of medical devices guarantees that the medical device complies with the provisions of this act and the European Union regulating medical devices.
11. Device subcategory means a set of devices having common areas of intended use or common technology of production.
12. Authorised representative of the manufacturer of medical devices (hereinafter: manufacturer’s representative) means a legal entity with the registered office in the European Union which is explicitly authorised by the manufacturer of medical devices with the registered office in a third country to represent it and to which the competent authorities may turn in relation to the obligations of the manufacturer of medical devices.
13. Legal entities means legal persons, independent sole proprietors and other individuals engaging in a registered activity or performing such activity on the basis of a regulation or articles of association.
14. Intended purpose of use means the use for which the medical device is intended according to the data supplied by the manufacturer of the medical device on the labelling, in the instructions for use and/or in promotional materials.
15. Notified body means a body carrying out the procedures of establishing conformity with this act and the regulations issued on its basis and the provisions of the European Union regulating medical devices, meeting the terms and conditions, being appointed and notified with the European Commission in accordance with this act or the regulations of the European Union member state in which it has its registered office.
16. Manufacturer of medical devices means the legal entity with responsibility for the design, manufacture, packaging and labelling of a medical device before it is placed on the market under his own name, regardless of whether these operations are carried out by that person or on their behalf by a third party.
17. Wholesale of medical devices means purchasing of medical devices and selling them to legal entities which buy them to perform their profession or registered activity.
18. Retail of medical devices means purchasing of medical devices and their further sale to individuals for personal use.
19. Generic medical device group means a set of medical devices having the same or similar intended uses or commonality of manufacturing technology allowing them to be classified in a generic manner not reflecting their specific characteristics.
20. Third countries means Non-Member States of the European Union or signatories to the EEA Agreement.
21. Recall means a measure to prevent access to a medical device on the market.
22. Import of a medical device means wholesale from third countries into the territory of the European Union.
23. Vigilance of medical devices (hereinafter: vigilance) means the system of establishing, collecting and evaluating complications involving medical devices and other findings about their safety, as well as measures for reducing the related risk.
24. A complication involving a medical device means any malfunction or deterioration in the characteristics and/or performance of a medical device from medical or technical point of view, as well as any inadequacy in the labelling or the instructions for use which might lead to or might have led to the death of a patient, user or a third person, or to a serious deterioration in his state of health.
 

Article 10
(Authority)
(1) The competent minister (hereinafter: the minister) for medical devices shall be the minister competent for health, unless otherwise stipulated herein.
(2) The body competent for medical devices shall be the Public Agency of the Republic of Slovenia for Medicinal Products and Medical Devices.
(3) The body competent for medical devices shall decide in administrative matters at first instance in accordance with the act governing the general administrative procedure, unless otherwise stipulated by this Act.
(4) Unless otherwise stipulated by this Act, the body competent for medical devices must request that any incomplete applications be supplemented within 30 days of receiving such application and set a deadline in which the applicant (hereinafter: the applicant) must supplement such application.
(5) The ministry responsible for health shall decide on complaints against the decisions of the competent body responsible for medical devices.
 

Article 11
(Co-operation between bodies and communication of data)
(1) The body competent for medical devices shall co-operate with the authorities competent for medical devices from other Member States, with the European Commission and with other competent institutions, and exchange data with the aim of using harmonised provisions regulating medical devices.
(2) The body competent for medical devices, or legal entities, must provide the following data for the registration in the European database of medical devices (hereinafter: Eudamed):
- registration of manufacturers of medical devices, manufacturer representatives and medical devices, with the exception of data on medical devices made for individual users,
- EC certificates,
– vigilance and
- clinical investigations of medical devices.
(3) The minister shall lay down the details for the data referred to in the previous paragraph and the method of reporting them.
 

Article 12
(Expert advice)
The body competent for medical devices shall provide expert advice upon the request of the legal entities, regarding:
- translation of the instructions for use and labelling of a medical device,
- differentiations between medical devices and other products pursuant to Article 15 of this Act;
- classification of medical device into the adequate class pursuant to Article 16 of this Act.
 

Article 13
(Committees and specialists)
(1) The body competent for medical devices has established permanent and temporary committees and uses the services provided by individual specialists (hereinafter: the specialist). Within the scope of their operation the committees for medical devices and individual specialists shall have a consultative role and shall be professionally independent and autonomous.
(2) The committees for medical devices and individual specialists shall be appointed by the body competent for medical devices from among the established experts in pharmacy, medicine and other natural and technical sciences, to discuss and issue opinions in expert areas requiring special knowledge.
(3) Members of the committees for medical devices and individual specialists must not be biased and must act in accordance with the applicable regulations, and may not enable unjustified benefits or prioritise individual applicants and must comply with the provisions on confidentiality of data made available to them while performing tasks.
 

Article 14
(Specialists in the bodies of the European Union)
The specialists co-operating with the competent bodies of the European Union responsible for medical devices shall be appointed by the body competent for medical devices.
 

Article 15
(Differentiation between medical devices and other products)
(1) When deciding on the classification of the product among medical devices or other products, their main purpose of use needs to be taken into account.
(2) If a medical device was put on the market only for the purpose of using a medicinal product, it is subject to the provisions of this Act.
(3) If a medical device was put on the market to be combined with a medicinal product to represent a single product, intended only to be used in the given combination and not to be re-used, such single product is subject to the provisions of the act regulating medicinal products. The characteristics of the medical device, related to its safety and performance must correspond to the essential requirements from this Act.
(4) Where a medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of the provisions on medicinal products and which is liable to act upon the body with action ancillary to that of the medical device, that products is considered a medical device.
(5) Where a medical device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product constituent or a medicinal product derived from human blood or human plasma within the meaning the provisions regulating medicinal products and which is liable to act upon the human body with action that is ancillary to that of the device, that device shall be considered a medical device.
(6) If the purpose of the manufacturer of medical devices is for the medical device to be used as personal protection equipment in accordance with the provisions on personal protection equipment, the product must meet the appropriate requirements for the safety and health, in line with the provisions on personal protective equipment.
(7) In case of doubt regarding the classification of a product among medical devices, the classification shall be decided upon by the body competent for medical devices, either on the basis of the submitted application or ex officio.
(8) The detailed contents of the application referred to in the previous paragraph shall be laid down by the minister.
 

II. CLASSIFICATION OF MEDICAL DEVICES
Article 16
(Classification of medical devices)
(1) Medical devices shall be classified on the basis of the level of risk for the user, the location and method of use, dependence on the power source, useful life and other characteristics.
(2) According to their risk potential for the user, medical devices shall be classified as follows:
- Class I - medical devices constituting a low risk potential for users;
- Class IIa - medical devices constituting a higher risk potential for users;
- Class IIb - medical devices constituting a high risk potential for users; and
- Class III - medical devices constituting the highest risk potential for users.
(3) According to their place and method of use and other characteristics of the product, medical devices shall be classified into invasive and non-invasive.
(4) According to source of energy, medical devices shall be classified into active and inactive.
(5) According to their risk potential for the user, in vitro diagnostic medical devices shall be classified as follows:
- List A
- List B
- In vitro diagnostic medical devices for self-testing not included in List A or B and
- other in vitro diagnostic medical devices.
(6) The minister shall lay down more detailed rules for the classification of medical devices and classification of in vitro diagnostic medical devices.
 

Article 17
(Decision with regard to classification)
In case of disagreement regarding the correct classification of a medical device in accordance with the previous Article, the classification shall be decided upon by the body competent for medical devices.
 

Article 18
(Derogation clause)
The body competent for medical devices shall submit to the European Commission a grounded request for the adoption of the necessary measures, should they believe that:
- the use of classification rules requires a decision on the classification of a medical device or a category of medical devices,
- a medical device or a group of medical devices should be classified into another class,
- it is necessary to establish conformity of a medical device, active implantable medical device, in vitro diagnostic medical device or a group of medical devices with another procedure for determining conformity,
- a decision is required as to whether a particular product or product group belongs among medical devices referred to in Articles 3 to 8 hereof.
 

III. REQUIREMENTS FOR MEDICAL DEVICES
Article 19
(Conditions for placing on the market and putting into service or beginning of use)
(1) Medical devices may be placed on the market and/or put into service or use only if they comply with the requirements laid down in this Act and the regulations issued on its basis when duly supplied and properly installed, maintained and used in accordance with their intended purpose.
(2) Legal entities using medical devices while performing their activity must maintain them in accordance with the instructions of the manufacturer of medical devices.
 

Article 20
(Essential requirements for medical devices)
(1) Medical devices must satisfy both general and specific essential requirements.
(2) General requirements for medical devices are:
- they must be designed, manufactured, maintained and used in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety;
- they must be designed so as to, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the medical device is intended to be used (design for patient safety);
- their designing requires consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users).
(3) Specific requirements for medical devices are:
- chemical, physical and biological properties of medical devices;
- microbiological quality of medical devices;
- planning and characteristics of medical devices, depending on the environment;
- medical devices with a measuring function;
- protection against radiation;
- medical devices connected to or equipped with an energy source;
- labelling of medical devices and package leaflet.
(4) Where a relevant hazard exists, medical devices and active medical devices, which are also machinery shall meet the essential health and safety requirements set out in provisions on technical requirements and on the establishment of conformity, if the health and safety requirements are more specific than the essential requirements, stipulated hereby.
(5) More detailed essential requirements for medical devices are laid down by the minister.
 

Article 21
(Application of standards and technical regulations)
(1) Medical devices compliant with the requirements of national standards, adopted on the basis of harmonised standards, shall be deemed to be compliant with the requirements stipulated by this Act and the provisions issued on its basis. The minister shall publish in the Official Gazette of the Republic of Slovenia the list of standards to be used in order to ensure conformity of a medical device with the requirements of this Act and the provisions issued on its basis.
(2) Reference to the standards includes monographs in the European Pharmacopeia or in the Slovene national supplement to the European Pharmacopeia in case of a product that is a combination of a medicinal product and a medical device.
(3) If the body competent for medical devices believes that harmonised standards from the first paragraph hereunder do not comply with the requirements of this Act, it shall initiate the implementation of the protection clause in accordance with Article 26 hereof.
(4) In the case of in vitro diagnostic medical devices from the List A and, if necessary also for in vitro diagnostic medical devices from the List B, the reference to the standards shall also mean reference to common technical specifications. These common technical specifications shall establish appropriate performance evaluation and re-evaluation criteria, batch release criteria, reference methods and reference materials and shall be published in the Official Gazette of the European Union. Manufacturers of medical devices must ensure that in vitro diagnostic medical devices correspond to common technical specifications. If for duly justified reasons manufacturers do not comply with those specifications they must adopt solutions of a level at least equivalent thereto.
 

IV. CONFORMITY ASSESSMENT PROCEDURE OF MEDICAL DEVICES
Article 22
(Conformity assessment procedure)
(1) The conformity assessment procedure is a procedure used for direct or indirect establishment and assessment of whether medical devices, their production or performance quality corresponds to the conditions laid down by the provisions of the European Union regulating medical devices, to this Act and to the implementing regulations issued on its basis.
(2) The procedure for assessing the conformity of medical devices, described in the previous paragraph shall depend on the classification of the medical device in view of the risk for their users, namely:
- The conformity of medical devices of class I with the prescribed requirements shall be assessed by the manufacturer of the product. An exception is medical devices of class I with a measuring function and those put on the market sterile and considered products of class II in terms of the measuring function and assurance of sterility;
- The conformity, manufacturing and performance quality of medical devices of classes IIa, IIb and III with the prescribed requirements shall be assessed by the notified body.
(3) Conformity assessment procedures shall comprise:
- an integral quality assurance system;
- EC type-examination;
-EC verification;
- a manufacturing quality assurance system;
- a product quality assurance system;
- an EC declaration of conformity.
(4) Where the conformity assessment procedure involves the intervention of a notified body, the manufacturer of medical devices, or his authorised representative, may apply to a notified body of his choice with the registered office in a European Union Member State within the framework of the tasks for which the body has been notified. The notified body and the manufacturer of medical devices, or his authorised representative, may agree in writing about the process and conclusion of establishing conformity.
(5) Conformity assessment procedures shall be detailed by the minister.
 

Article 23
(EC certificate and EC declaration of conformity)
(1) The process of assessing conformity of medical devices of class IIa, IIb and III, active implantable medical devices and in vitro diagnostic medical devices starts with the notified body by submission of an application. The application must contain proof on the fulfilment of conditions stipulated by the provision from the fifth paragraph of the previous article.
(2) The notified body may require any information or data, which is necessary for assessing conformity. The application, evidence and letters related to the procedures of establishing conformity must be written in the Slovene language or another language understood by the notified body.
(3) Prior to initiating the process of assessing conformity, the notified body must check the classification of the product among medical devices, which is performed by manufacturer hereunder.
(4) After having assessed the conformity, the notified body shall issue an EC certificate with the validity of up to five years. The validity can be extended by a maximum of five years on the basis of an application of the manufacturer of medical devices or his representative, which must be submitted within the deadline agreed in writing by the notified body and the applicant.
(5) Notwithstanding the provision of the previous paragraph, the notified body shall issue an EC certificate of unlimited duration after having assessed the conformity of a medical device according to the process of EC verification.
(6) Before a medical device is put on the market, with the exception of those made for individual users or for clinical investigation, the manufacturer of medical devices shall draft an EC statement of conformity and affix a CE mark on the medical device.
(7) The manufacturer of medical devices or the manufacturer’s representative must keep the EC statement of conformity, technical documentation on a medical device and the certificates issued by the notified bodies and make them available to an inspector for five years after having manufactured the last medical device or 15 years after having manufactured the last active medical device to which the documentation refers.
 

Article 24
(Statement on medical devices made for an individual user and medical devices intended for clinical investigations)
(1) For medical devices made for an individual user and medical devices intended for clinical investigations, the manufacturer of medical devices or his representative must compile a written statement containing data on the manufacturer of medical devices, medical device and other relevant data.
(2) When putting on the market medical devices of class IIa, IIb and III, which were made for an individual user, the written statement referred to in the previous paragraph must be made available to the user of the specific medical device. The statement shall contain the user’s name or date in encoded form.
(3) The statement from the first paragraph hereunder shall be kept by the manufacturer of medical devices for a period of time of at least five years and in the case of implantable devices the period shall be at least 15 years.
(4) More detailed contents of the statement referred to in the first paragraph hereunder and the type of documentation and the content of the statement for in vitro diagnostic medical devices for evaluating their performance from the second paragraph of Article 38 hereof shall be laid down by the minister.
 

Article 25
(Emergency derogations)
Based on appropriately grounded request by the applicant, the body in charge of medical devices may approve the marketing and use in the Republic of Slovenia of those medical devices that have not been subjected to the conformity assessment procedures in emergency situations (epidemics, poisoning, nuclear or radiological accident or similar), or for other reasons, in the event of the protection of public health.
 

Article 26
(Safeguard clause)
(1) Where a body competent for medical devices ascertains that the devices, when correctly installed, maintained and used for their intended purpose may compromise the health and/or safety of patients, users or, where applicable, other persons, or the safety of property, it shall immediately take all appropriate interim measures to withdraw such devices from the market or prohibit or restrict their being placed on the market or put into service.
(2) The body competent for medical devices shall immediately inform the European Commission of any measures from the previous paragraph, stating the reasons for such a decision. It shall specifically indicate if the reason lies in non-compliance with the essential requirements hereof, incorrect application of standards referred to in Article 21 hereof or deficiencies in the standards themselves.
(3) The body competent for medical devices shall take measures against anybody who affixes the CE mark to a medical device which is not in compliance herewith. They shall inform the European Commission and the bodies of other Member States of the European Union, competent for medical devices, of any measures taken.
(4) The body competent for medical devices shall inform the public, through media release, of any measures taken in accordance with the first paragraph hereunder.
 

Article 27
(Particular health monitoring measures)
(1) Where a body competent for medical devices considers in relation to a given product or group of products that, in order to ensure protection of health and safety and/or to ensure that public health requirements are observed, such products should be withdrawn from the market, or their placing on the market and putting into service should be prohibited, restricted or subjected to particular requirements, it may take any necessary and justified transitional measures.
(2) The body competent for medical devices shall immediately inform the European Commission and other Member States of the European Union of any measures from the previous paragraph, stating the reasons for such a decision.
(3) The body competent for medical devices shall inform the public, through media release, of any measures taken in accordance with the first paragraph hereunder.
 

V. CE MARKING
Article 28
(CE marking)
(1) Medical devices meeting the requirements of this act and the regulations issued on its basis and the provisions of the European Union regulating medical devices must be labelled with the CE marking when put on the market. The CE marking must be clear, legible and indelible, also in the sterile pack, sales packaging and instructions for use.
(2) The CE marking affixed to medical devices of class IIa, IIb and III, on active implantable medical devices and on in vitro diagnostic medical devices must be accompanied by an identification number of the notified body in charge of implementing conformity assessment procedures.
(3) The CE marking is laid down by the minister.
 

Article 29
(Exceptions regarding the CE marking)
(1) The provisions of this act shall not apply to medical devices intended for clinical investigations, for medical devices made for individual user and for in vitro diagnostic medical devices for the evaluation of performance from Article 38 of this Act.
(2) For medical devices presented at fairs, exhibitions and presentations, no CE marking shall be required if they are visibly marked as intended to be put on the market or into service.
 

Article 30
(Prohibited affixing of the CE marking)
(1) It is prohibited to affix the CE marking to the products that are not medical devices on the basis of this Act.
(2) It is prohibited to affix the CE marking to the products that are not in compliance with this Act.
(3) It is prohibited to affix the CE marking to the products contrary to the provisions of this Act.
(4) It is prohibited to affix marks or inscriptions similar to the CE marking which are likely to mislead third parties with regard to the meaning or the graphics of the CE marking.
(5) It is prohibited to affix to a medical device, packaging or attached instructions for use any other marking that would reduce the visibility or legibility of the CE marking, cover it or cause any doubts as to the marking.
 

Article 31
(Particular procedure for systems and packs of medical devices)
(1) Where medical devices bearing the CE marking are joined into a system or package with the aim of putting it on the market in the form corresponding to their intended purpose and within the limits of use specified by their manufacturers, there is no need to perform the conformity assessment procedure and affix additional CE markings to the system or pack.
(2) The data prescribed for a system or pack of medical devices must be attached and, where appropriate, also the data on medical devices joined into the system or pack.
(3) A legal entity putting on the market the systems or packs of medical devices must issue a written statement that:
- he has verified the mutual compatibility of the devices in accordance with the manufacturers' instructions and has carried out his operations in accordance with these instructions;
- he has packaged the system or procedure pack and supplied relevant information to users; and
- all activities were subjected to appropriate methods of internal control and inspection.
(4) The legal entity shall keep the statement referred to in the previous paragraph for at least five years and make it available to the body competent for medical devices, upon its request.
(5) Where systems or procedure packs incorporate devices which do not bear a CE marking or where the chosen combination of devices is not compatible in view of their original intended use, the system or procedure pack shall be treated as a medical device in its own right and as such be subjected to the relevant conformity assessment procedure pursuant to Article 22 hereof and afterwards affixed the CE marking.
 

Article 32
(Sterilisation of systems and packs)
(1) Any legal person who sterilises, for the purpose of placing on the market, systems or procedure packs or other CE-marked medical devices designed by their manufacturers to be sterilised before use, shall follow the conformity assessment procedure in order to ensure integral quality or production quality system in accordance with Article 22 hereof. The procedure and intervention of a notified body shall be used for assuring sterility until opening or damage to the sterile package. After sterilisation there is no need to affix a new CE marking.
(2) The legal entity shall draw up a written declaration stating that sterilization has been carried out in accordance with the manufacturer's instructions. The legal entity shall keep the declaration for at least five years and make it available to the body competent for medical devices, upon its request.
 

VI. LABELLING AND PACKAGE LEAFLET
Article 33
(Labelling and package leaflet)
(1) Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer of medical devices. Such information is stated on the packaging or label and in the instructions for use.
(2) As far as practicable and appropriate, the information needed to use the medical device safely and correctly must be set out on the device itself and/or on the packaging for each unit or, where appropriate, on the sales packaging. If individual packaging of each unit is not practicable, the information must be set out in the leaflet supplied with one or more medical devices.
(3) Information marking the medical device and the purpose of use, and the name and address of the manufacturer of the medical device or his representative must be stated on the sales packaging.
(4) The instructions for use must be included in the sales packaging of the medical device, with the exception of medical devices of class I and IIa or in justified and exceptional cases for in vitro diagnostic medical devices, if they can be used safely also without the instructions for use; nevertheless, such information must be made available to the user upon request.
(5) The instructions for use must be written in the Slovene language, legible and understandable for the user, and must contain the date of issue or the date of last revision or amendment. If they have been translated into the Slovene language, the content of the translation must be the same as that of the original instructions for use. If a medical device is intended solely to be used for performing a registered activity, the instructions for use can be written in the language understandable for the user.
(6) The minister shall lay down detailed information to be attached to the sales packaging, label and instructions for use of a medical device or systems and packs of medical devices.
 

VII. NOTIFIED BODIES
Article 34
(Conditions for notified body)
(1) Prior to carrying out the conformity assessment procedures from Article 22 hereof, a legal entity with the registered office in the Republic of Slovenia must be appointed by a decision of the body competent for medical devices and notified to the European Commission.
(2) In view of the type and scope of conformity assessment procedures, the notified bodies must meet the following conditions:
- have an adequate number of experts with adequate experience and knowledge necessary to assess the medical functionality and performance of devices, their quality or production quality system;
– have adequate premises, devices and equipment for assessing conformity of medical devices;
- have established operational quality assurance system;
- keep appropriate documentation on the procedures of assessment and verification of medical devices and manufacturers of medical devices.
(3) The minister shall lay down the detailed conditions to be met by a notified body and the content of the application for the appointment of the body for implementing procedures and establishing conformity.
 

Article 35
(Appointment and notification procedure)
(1) The procedure of appointing a the body for carrying out the conformity assessment procedures with the registered office in the Republic of Slovenia shall be initiated by the submission of an application with the body competent for medical devices. In the application, the applicant must provide information and evidence on the fulfilment of conditions from the previous article, indicating which medical devices are to be subjected to conformity assessment procedure in accordance with the provisions of Articles 16 and 22 hereof, and attach documents proving his qualification to meet the requirements hereof (e.g. accreditation document or qualification report, if available).
(2) After having received a complete application, the body competent for medical devices shall appoint a verification committee (hereinafter: the committee) which shall be composed of the experts in the operation of the body competent for performing conformity assessment procedures. The committee shall issue an opinion on the fulfilment of conditions by the applicant and on potential measures for eliminating the established deficiencies.
(3) After having received an opinion of the committee on the fulfilment of the requirements arising from this Act, the body competent for medical devices shall issue a decision on the appointment of a body competent for performing conformity assessment procedures or rejection of appointment within 60 days of receiving a complete application.
(4) When issuing the decision on the appointment of a body competent for performing conformity assessment procedures the body competent for medical devices shall send to the minister competent for the market a decision for notification with the European Commission.
(5) The minister competent for the market shall inform the European Commission and other Member States of the European Union on the appointment of the body competent for performing conformity assessment procedures together with the data on the tasks assigned to it within 15 days of receiving the decision referred to in the previous paragraph.
(6) After the European Commission has performed the procedure of establishing the fulfilment of the required conditions, the body competent for performing conformity assessment procedures shall obtain the identification number and can start performing tasks of the notified body.
 

Article 36
(Monitoring and revocation of appointment)
(1) The body competent for medical devices shall monitor the implementation of conformity assessment procedures from Article 22 hereof, carried out by the notified body, and the fulfilment of conditions regarding the notified body from Article 34 hereof.
(2) The body competent for medical devices shall revoke the decision on appointment should they find out that the notified body does not meet the conditions from Article 34 of this Act, of which it shall immediately inform the ministry competent for the market.
(3) The minister competent for the market shall immediately inform the European Commission and other Member States of the European Union of the revocation of appointment, referred to in the previous paragraph.
(4) The appointment and revocation of appointment shall be published on the website of the body competent for medical devices.
 

Article 37
(Working methods of the notified body)
(1) The notified body shall be independent and autonomous in performing its tasks and competences.
(2) A notified body may not be a designer, manufacturer, supplier or user of medical devices inspected, or a representative of such persons.
(3) Because of the conflict of interest, the personnel of the notified body may not enable unjustified benefits or prioritise individual applicants. They must respect the confidentiality of technical data on medical devices and business data on the manufacturers of medical devices.
(4) The notified body must inform the body competent for medical devices of the issued, amended and supplemented EC certificates and submit them within 30 days of their issue.
(5) The notified body must inform the body competent for medical devices and other notified bodies with the registered office in the Member States of the European Union on temporarily suspended or revoked EC certificates or rejected requests for their issue and, if requested, also on the issued EC certificates and other adequate information no later than within 15 days of revocation, cancellation, rejection of request or request.
(6) Where a notified body finds that pertinent requirements of this Act have not been met or are no longer met by the manufacturer of medical devices or where a certificate should not have been issued, it shall, taking account of the principle of proportionality, suspend or withdraw the certificate issued or place any restrictions on it unless compliance with the requirements hereunder is ensured by the implementation of appropriate corrective measures by the manufacturer. In the case of suspension or withdrawal of the certificate or of any restriction placed on it or in cases where an intervention of the body competent for medical devices may become necessary, the notified body shall inform its competent authority thereof.
(7) The body competent for medical devices shall immediately inform the European Commission and bodies competent for medical devices from other Member States of the European Union of any measures from the previous paragraph.
(8) Upon their request, the notified body must submit to the body competent for medical devices and the competent inspector the documentation on the procedures of assessing conformity of medical devices and verification of the manufacturers of medical devices, including the financial documents on the operations of the notified body.
(9) Information on EC certificates from the fourth and the fifth paragraph hereunder, with the exception of data on rejected requests for the issue of EC certificates shall not be considered confidential.
 

VIII. CLINICAL INVESTIGATIONS OF MEDICAL DEVICES
Article 38
(Clinical investigations of medical devices)
(1) Clinical investigation of a medical device shall mean any investigation whose objective is to establish that the safety and performance of a medical device complies with those indicated by the manufacturer of medical devices.
(2) The safety and performance of in vitro diagnostic medical devices shall be established on the basis of the studies of evaluating their performance.
 

Article 39
(Procedure of notifying a clinical investigation of medical devices)
(1) The applicant for a clinical investigation can be the manufacturer of medical devices or his representative.
(2) Before the start of a clinical investigation, the applicant must notify the clinical investigation to the body competent for medical devices. The application for a clinical investigation must contain data on the medical device, the plan of clinical investigation, the opinion of the National Medical Ethics Committee and other information or documentation determined by the minister.
(3) Before the start of a clinical investigation, the applicant must notify the study of the evaluation of performance of an in vitro diagnostic medical device to the body competent for medical devices. The application must contain data on in vitro medical device, the plan of performance evaluation and other information or documentation determined by the minister.
(4) The provisions from the previous paragraph shall also apply to medical devices with the CE marking where the objective of clinical investigation is the use of medical devices for the purposes that are not the subject of the conformity assessment procedure.
(5) The body competent for medical devices shall decide on the applications for notification of a clinical investigation. The body competent for medical devices shall issue a decision on the notification of a clinical investigation within 60 days of receiving a complete application. If there is no response from the competent body it shall be deemed that the notification has been approved and the clinical investigation can commence.
(6) If the body competent for medical devices rejects the notification of a clinical investigation, it shall give reasons for rejection in the decision and ground them in terms of the protection of public health or public interest. A rejection of a clinical investigation must be notified to the bodies competent for medical devices in the Member States of the European Union and the European Commission.
(7) The minister shall define the detailed contents of the application for notification of a clinical investigation and any changes to the clinical investigation.
 

Article 40
(The procedure of clinical investigation of medical devices)
(1) The objectives and methods of the implementation of clinical investigations of medical devices and the evaluation of clinical data and other requirements for clinical investigations of medical devices shall be determined by the minister.
(2) The applicant shall notify the body competent for medical devices of any complications related to medical devices that occurred during the clinical investigation within seven days of the event.
 

Article 41
(Notification of a change to a clinical investigation of medical devices)
(1) The applicant for the clinical investigation must inform the body competent for medical devices of any changes to an ongoing clinical investigation.
(2) The notified change can be introduced if the body competent for medical devices does not issue a negative decision within 30 days of receiving a complete application for such change.
 

Article 42
(discontinuation of a clinical investigation of medical devices)
(1) The body competent for medical devices may, for the purpose of protecting public health or health of investigated subjects, order that a trial be temporarily discontinued or adequately changed.
(2) The body competent for medical devices shall immediately inform the bodies competent for medical devices from other Member States of the European Union and the European Commission of the discontinuation of a clinical investigation and the reasons for that. The bodies competent for medical devices from the relevant Member States of the European Union shall be informed of the request for a change to or temporary discontinuation of a clinical investigation and the reasons for that.
(3) The applicant for a clinical investigation may at any point decide to discontinue a clinical investigation and inform the body competent for medical devices of the reasons for discontinuation within 15 days after the discontinuation. The body competent for medical devices must inform the bodies competent for medical devices from other Member States of the European Union and the European Commission of early discontinuation for safety reasons.
 

Article 43
(Completion of a clinical investigation of medical devices)
The applicant of a notified clinical investigation of a medical device must inform the body competent for medical devices of the completion of a clinical investigation within 30 days of the completion and send it the final report.
 

IX. MANUFACTURE OF MEDICAL DEVICES
Article 44
(Requirements for a manufacturer of medical devices)
(1) A manufacturer of medical devices must provide the following for the manufacturing of medical devices:
- adequately skilled personnel, premises, equipment and manufacturing procedures, keeping of documentation in view of the established operational quality assurance system, so as to guarantee that the manufactured medical devices are in compliance with the essential requirements hereof, which do not jeopardise the health and safety of patients, users or third persons and that they are manufactured in consideration of the scientific and technological achievements and in such a way that their risk of use is reduced or eliminated.
- a person in charge of monitoring and reporting on complications related to medical devices and measures to be taken in the event of potential risk;
- insurance of liability for potential damages caused to a patient, user or a third person as a result of inadequate quality or safety of a medical device.
(2) The detailed requirements for the manufacturers of medical devices referred to in the previous paragraph shall be laid down by the minister.
 

Article 45
(Entry in the register of the manufacturers of medical devices)
(1) A manufacturer of medical devices with the registered office in the Republic of Slovenia must notify itself to the body competent for medical devices for registration in the register of manufacturers of medical devices within 15 days of putting the manufactured medical devices on the market and state the name or company name, registered office or address and address of the manufacturing units and a list of manufactured medical devices.
(2) The body competent for medical devices shall immediately inform the European Commission and the competent bodies of the Member States of the European Union of the data from the previous paragraph.
(3) The data from the first paragraph hereunder shall be laid down by the minister.
 

Article 46
(Change of data and deletion from the register of the manufacturers of medical devices)
(1) A manufacturer of medical devices shall report any change of data referred to in the previous article to the body competent for medical devices within 15 days after the onset of the change.
(2) A body competent for medical devices shall delete a manufacturer of medical devices from the register of manufacturers of medical devices ex officio if the manufacturer of medical devices is dissolved or based on a written request of the manufacturer of medical devices.
 

Article 47
(Manufacturer representative)
(1) A representative of a manufacturer of medical devices with the registered office in the Republic of Slovenia must notify himself to the body competent for medical devices for registration of the manufacturer in the register of manufacturers of medical devices within 15 days of putting the manufactured medical devices, for which they are authorised, on the market.
(2) Upon notification, the manufacturer’s representative must state his name or company name and address or registered office of the represented manufacturer of medical devices and a list of medical devices put on the market under authorisation of the manufacturer of medical devices.
(3) A manufacturer’s representative shall report any change of data referred to in the previous paragraph to the body competent for medical devices within 15 days after the onset of the change.
(4) A body competent for medical devices shall delete a representative of a manufacturer of medical devices from the register of manufacturers of medical devices ex officio if he is no longer a representative of the manufacturer of medical devices or is dissolved, or based on a written request of the manufacturer of medical devices.
(5) The body competent for medical devices shall immediately inform the European Commission and the competent bodies of the Member States of the European Union of the data from the second paragraph hereunder.
(6) The data from the second paragraph hereunder shall be laid down by the minister.
 

Article 48
(Obligations of legal entities putting medical devices on the market under their own name)
(1) The obligations of this Act to be met by manufacturers of medical devices also apply to the legal entities who assemble, package, process, fully refurbish and/or label one or more ready-made products and/or assigns to them their intended purpose of functioning or use as a device, or sterilise them, all with a view to their being placed on the market under their own name.
(2) The provisions of the previous paragraph do not apply to persons who assemble or adapt medical devices already on the market to their intended purpose for an individual patient.
 

Article 49
(Notification of medical devices)
(1) A manufacturer of medical devices or his representative with the registered office in the Republic of Slovenia must notify to the body competent for medical devices any medical devices to be entered in the register of medical devices within 15 days of putting them on the market.
(2) Manufacturers of medical devices and representatives of manufacturers must submit to a body competent for medical devices, upon the latter’s request, any documentation on active implantable medical devices, medical devices of class IIa, IIb and III, medical devices made for an individual user and in vitro diagnostic medical devices put into use in the Republic of Slovenia.
 

Article 50
(Entry in the register of medical devices)
(1) The procedure for the entry into the register of medical devices shall be initiated by an application submitted by a manufacturer of medical devices or his representative with registered office in the Republic of Slovenia. In addition to the general information on the manufacturer of medical devices or his representative, the application shall also contain data and documents on medical devices concerned, namely:
- name or generic name of medical device,
- class or classification of medical device,
- description and purpose of use of medical device,
- EC declaration of conformity,
- copy of EC certificate,
- instructions for use, and
- special instruction in the case of new in vitro diagnostic medical device that has not been available on the market of the European Union in the last three years for the adequate analyte or another parameter or when made with a technology that has not been used in the European Union in the last three years for the adequate analyte or another parameter.
(2) A body competent for medical devices shall issue a decision on the entry of a device in the register of medical devices within 60 days of receiving a complete application and enter a medical device or a group of devices into the register of medical devices.
(3) A manufacturer of medical devices or his representative with the registered office in the Republic of Slovenia shall report any change of data referred to in the first paragraph hereunder to the body competent for medical devices within 15 days after the onset of the change.
(4) The detailed contents of the application for the entry in the register of medical devices shall be laid down by the minister.
 

Article 51
(Declaration of free sale of a medical device)
(1) A body competent for medical devices may issue a declaration to a manufacturer of medical devices with the registered office in the Republic of Slovenia, upon his request, to confirm that the relevant medical device or a group of medical devices was put on the market in accordance with the provisions of the European Union regulating medical devices and with this Act and any implementing regulations issued on its basis, and that there are no restrictions for putting the medical device concerned on the market.
(2) The detailed contents of the application for the issue of a declaration on free sale of a medical device referred to in the previous paragraph shall be laid down by the minister.
 

X. MARKETING OF MEDICAL DEVICES
Article 52
(Wholesaling of medical devices)
(1) Only the legal entities that meet the conditions for performing the trade activity, as laid down by the relevant regulations on trade, may wholesale medical devices.
(2) A legal entity referred to in the previous paragraph must notify itself to the body competent for medical devices for registration in the register of legal entities engaged in wholesaling medical devices within 15 days of the beginning of wholesaling medical devices.
(3) Legal entities wholesaling medical devices must:
- take due care to ensure that all medical devices put on the market are compliant with the provisions of this Act;
- verify if the prescribed CE marking had been affixed to medical devices before they are put on the market and if they had been equipped with the instructions for use and other data stipulated by this Act;
- provide such storage and transport conditions that preserve the compliance of a medical device with the requirements hereof;
- have appointed a person responsible for the vigilance of medical devices with the minimum level of education V and qualification for handling the wholesaled medical devices.
(4) If a legal entity placed on the market a medical device they believe or reasonably judge to be incompliant with the provisions of this Act, they shall immediately inform the manufacturer of medical devices or the manufacturer’s representative and ensure that adequate measures are taken to eliminate deficiencies or, if necessary, withdraw or recall a medical device. If a medical device threatens the life or health of people, a legal entity shall immediately inform the body competent for medical devices, indicating the Member States of the European Union in which the medical device concerned was put on the market and submitting the data on non-compliance with the requirements and measures adopted to eliminate them.
(5) Upon the request of a body competent for medical devices, a legal entity wholesaling medical devices must submit all the necessary information on wholesaled medical devices and co-operate in the implementation of corrective measures in the scope of vigilance of medical devices.
(6) A legal entity wholesaling medical devices shall report any change of data referred to in the eighth paragraph hereunder to the body competent for medical devices within 15 days after the onset of the change.
(7) The body competent for medical devices shall delete the legal entity wholesaling medical devices from the register of legal entities wholesaling medical devices ex officio, if the entity is dissolved or upon its written request.
(8) Detailed information for notifying a legal entity wholesaling medical devices shall be laid down by the minister.
 

Article 53
(Retailing of medical devices)
(1) Only the pharmacies and specialised or other stores that meet the conditions for performing the trade activity, as laid down by the relevant regulations on trade, may retail medical devices.
(2) Only medical devices that meet the requirements of this Act may be retailed.
(3) In vitro diagnostic medical devices for HIV self-testing may only be retailed in pharmacies.
(4) Medical devices may be retailed in specialised stores by legal entities that meet the conditions for performing the trade activity, have adequate premises and personnel qualified and trained to provide professional advice to the users of retailed medical devices
(5) A legal entity referred to in the previous paragraph must notify itself to the body competent for medical devices for registration in the register of legal entities engaged in retailing medical devices in specialised stores within 15 days of the beginning of retailing medical devices. Such legal entity shall report any change of data referred to in the eighth paragraph hereunder to the body competent for medical devices within 15 days after the onset of the change.
(6) The body competent for medical devices shall delete the legal entity retailing medical devices in specialised store from the register of legal entities retailing medical devices ex officio, if the entity is dissolved or upon its written request.
(7) Only medical devices that can be sold without the instructions for use inserted in the sales packaging, in accordance with the fourth paragraph of Article 33 hereof, and medical devices intended for protection against the spreading of contagious diseases can be retailed in other stores.
(8) The conditions from the fourth paragraph of this article and the information for notifying a legal entity retailing medical devices in a specialised store shall be laid down by the minister.
 

Article 54
(Import of medical devices)
(1) A legal entity may only import medical devices which are compliant with the requirements of this Act and for which the manufacturer of medical devices from a third country has an authorised representative with registered office on the territory of the European Union.
(2) A legal entity importing medical devices (hereinafter: an importer) must meet the conditions for performing the trade activity, as laid down by the relevant regulations on trade.
(3) In addition to the conditions stipulated by the previous paragraph, an importer must also meet the requirements laid down in the third, fourth and fifth paragraph of Article 52 hereof and:
- make sure that the manufacturer of medical devices carried out the adequate procedure of assessing conformity of the imported medical device;
- make sure that the manufacturer of medical devices compiled the adequate documentation on imported medical device;
- state on a medical device or, if that is not possible, on the packaging or instructions for use the name or company name, address or registered office to be contacted in relation to the information on medical device;
- make available for inspection the EC declaration of conformity of a medical device to the body competent for medical devices, upon its request, during the period in which the relevant medical device is being used.
(4) In addition to the conditions laid down in the previous paragraph, an importer retailing medical devices must also meet the conditions from the previous article.
(5) An importer must notify itself to the body competent for medical devices for registration in the register of legal entities engaged in wholesaling medical devices in accordance with Article 52 hereof.
(6) An importer from the fourth paragraph hereunder must also notify itself to the body competent for medical devices for registration in the register of specialised stores wholesaling medical devices in accordance with the previous article.
 

Article 55
(Free movement of medical devices)
It shall be prohibited to prevent the putting on the market or into use or service of medical devices that are compliant with the requirements of this Act and the implementing regulations issued on its basis.
 

XI. VIGILANCE OF MEDICAL DEVICES
Article 56
(Information on complications related to medical devices)
(1) Manufacturers of medical devices, their representatives and legal entities wholesaling medical devices must establish and maintain their own system of vigilance of medical devices that enables collection, evaluation and exchange of data on complications related to medical devices and co-operate with the body competent for medical devices.
(2) Collection of reports on complications related to medical devices and their evaluation shall be carried out by the body competent for medical devices which shall co-operate with the competent bodies of the Member States of the European Union.
(3) Manufacturers of medical devices, their representatives and legal entities wholesaling or retailing medical devices and importers with registered office in the Republic of Slovenia must inform the body competent for medical devices of any complication they are aware of within 24 hours.
(4) Providers of healthcare, pharmaceutical or other services must inform the body competent for medical devices of any complication they have been made aware of within 24 hours of the complication or their knowledge of it. They may also inform the manufacturer of medical devices or its representative of such complication.
(5) A report on a complication related to a medical device from the third and the fourth paragraph hereunder must indicate the name or company name and address or registered office of a legal entity or a provider of services and personal name of the reporter.
(6) A manufacturer of medical devices or its representative must research each complication related to a medical device of which they have been informed and inform the body competent for medical devices of its findings in accordance with the provision of the ninth paragraph hereunder.
(7) After having evaluated the complication related to a medical device, if possible in co-operation with the manufacturer or its representative, the body competent for medical devices shall inform the European Commission and bodies competent for medical devices from other Member States of the European Union of any measures taken to eliminate the complication related to a medical device.
(8) Providers of healthcare services who implant medical devices must keep a record of persons who have been implanted medical devices in order to ensure traceability and action in the event of any complications. The records shall comprise the patient’s personal name, address and telephone number, date of implantation, data on medical device (type and serial number) and on the manufacturer of medical devices.
(9) The minister shall lay down more detailed contents of the report from the fifth paragraph hereunder and the conditions for integral functioning of medical device vigilance system.
 

XII. ADVERTISING OF MEDICAL DEVICES
Article 57
(Advertising of medical devices)
Advertising of medical devices shall mean any form of information on medical devices, including door-to-door information, publication or inducement designed to promote the sale or use of medical devices.
 

Article 58
(Conditions for the advertising of medical devices)
(1) It shall be prohibited to advertise medical devices that do not meet the requirements from this Act.
(2) Notwithstanding the previous paragraph, legal entities may show medical devices that are not compliant with this Act at fairs, exhibitions, presentations and similar events, provided that they visibly indicate that the devices shall not be available for sale or use until they are made compliant with this Act or the implementing regulations issued on its basis.
(3) Medical devices used exclusively for performing medical activity may be advertised to the expert public. Expert public shall mean healthcare professionals as defined by the law regulating medical activity.
 

Article 59
(Method of advertising)
(1) The advertising of medical devices may not contain information which:
- indicates that the effects of the use of a medical device are guaranteed completely or that its usefulness equals that of any other treatment;
- indicates that the health of a person can only be enhanced by using the advertised medical device;
- indicates that the health of a person can only be enhanced by using the advertised medical device;
- are directed exclusively or principally at children;
- refers to a recommendation by scientists, health professionals or other publicly renowned persons who could encourage the use of a medical device because of their media influence;
- could, by a description or detailed representation of a case history, lead to erroneous self-diagnosis;
- refers, in improper, alarming or misleading terms, to claims of recovery;
- uses, in improper, alarming or misleading terms, pictorial representations of changes in the human body caused by disease or injury, unless presented in accordance with the established ethical and moral principles; or
- violate or abuse human dignity.
(2) Where medical devices are being promoted to expert community, no gifts, pecuniary advantages or benefits in kind may be given, offered or promised unless they are of small value, as prescribed for public officials.
(3) It shall be prohibited to present the characteristics and purpose of use of a medical device in a misleading way.
(4) Samples of medical devices may be given to the general and expert publics under the terms and conditions laid down by the minister.
 

Article 60
(Prohibition of misleading presentation of products)
It shall be prohibited to put on the market or into use any products presented with the characteristics of a medical device if not classified as such pursuant to this Act.
 

Article 61
(Official records)
A body competent for medical devices shall keep:
- a register of medical devices the manufacturers of which, or their representatives, have their registered office in the Republic of Slovenia, containing a name or generic name of medical devices, their classification and name or company name of the manufacturer of medical devices or its representative;
- a register of manufacturers of medical devices with registered office in the Republic of Slovenia, containing a name or company name of the manufacturer of medical devices or its representative and the type of medical device manufactured or authorised to represent;
- register of legal entities wholesaling medical devices, containing a name or company name, address or registered office of a legal entity;
- register of specialised stores retailing medical devices, containing a name or company name, address or registered office of a legal entity and specialised store;
- list of notified bodies with the registered office in the Republic of Slovenia, containing a name company name, address or registered office of a notified body and type of tasks for which it had been appointed.
 

XIII. FEES
Article 62
(Fees)
(1) The applicant shall pay the following fees for the procedures stipulated hereunder to the body competent for medical devices unless otherwise stipulated hereby:
- for the cost of expert consulting under Article 12 hereof,
- for the procedure of classifying a product among medical devices under Article 15 hereof,
- for the procedure of appointing a notified body under Article 35 hereof,
- for the procedure of notifying a clinical investigation or its change under Articles 39 and 41 hereof,
- for the procedure of entering in the register of medical devices under Article 50 hereof,
- for the declaration on free sale of a medical device under the first paragraph of Article 51 hereof.
(2) Notified bodies with registered offices in the Republic of Slovenia shall pay annual fees to the body competent for medical devices for monitoring the procedures and assessing conformity and fulfilment of conditions in accordance with the first paragraph of Article 36 hereof.
(3) The amount of fees under the first and the second paragraph hereunder shall be laid down by the minister.
 

XIV. SUPERVISION
Article 63
(Competence for supervision)
(1) The body competent for medical devices shall exercise supervision over medical devices. The supervision tasks shall be performed by the inspectors for medical devices.
(2) Market inspectors shall inspect the implementation of the provisions of the first paragraph of Article 52, the first and the fourth paragraph of Article 53 and the second paragraph of Article 54 hereof, relating to the fulfilment of conditions stipulated by the provisions on trade.
 

Article 64
(Appointment of inspector)
(1) In order to be appointed inspector under the first paragraph of the previous article, a person must have:
- university level education,
- at least 5 years of work experience, and
- passed the professional examination for inspectors according to the law regulating inspection.
(2) Inspectors from the first paragraph of the previous article shall be appointed by the head of the body competent for medical devices in accordance with the law regulating civil servants.
 

Article 65
(Competences of inspectors)
(1) Inspectors shall have the position, rights and obligations laid down for the inspectors by the law regulating inspection and the law regulating civil servants.
(2) In addition to the competences laid down in the previous paragraph, an inspector shall also have the following competences and tasks:
- impose on a legal entity to harmonise the operations with the provisions of this Act and the regulations adopted on its basis within the specified deadline;
- prohibit the putting on the market or ordering withdrawal or recall of medical devices not in compliance with this Act;
- prohibit the use or putting into service, restricting or ordering cessation of use of medical devices not in compliance with this Act;
- ban the manufacture, clinical investigation or marketing of medical devices on the grounds of incompliance with prescribed conditions hereof;
- request all necessary information from the legal entity and insight into issued conformity documents and other documentation;
- order execution of appropriate tests and checks of medical devices in order to assess their conformity with regulations also after such products have been put on the market or come into use;
- order the destruction of non-conforming medical devices, if necessary for protection of the health and safety of people;
- collect sample medical devices and submit them for conformity assessment procedure;
- prohibit the presentation or advertising of medical devices that is not in compliance with the provisions of this Act;
- order the removal or destruction of the material used for illegal advertising of medical devices;
- order elimination of established incompliance with this act and the provisions issued on its basis;
- order measures to be taken by the legal entity in relation to the implementation of the vigilance system in accordance with this Act and the regulations issued on its basis;
- order to a notified body to harmonise operations with the requirements of this Act;
- order other measures necessary for the implementation of this Act and the regulations issued on its basis.
(3) An appeal against the measures stipulated under the previous paragraph, ordered by the inspector, shall not prevent their implementation.
 

XV. PENAL PROVISIONS
Article 66
(Penal provisions)
(1) A fine from 1,000 to 10,000 euros shall be imposed for an offence on a legal entity:
1. for failing to maintain medical devices in accordance with the provision laid down in Article 19, paragraph 2);
2. for failing to keep during the prescribed period or making available the documentation from the seventh paragraph of Article 23 hereof;
3. for failing to keep the statement on medical devices made for an individual user and medical devices intended for clinical investigations, within the deadlines in accordance with the third paragraph of Article 24 hereof;
4. for failing to attach to the system and package of medical devices intended for putting on the market or into use the prescribed information (the second paragraph of Article 31);
5. for failing to issue a written declaration, keeping it for five years or failing to make it available to the body competent for medical devices (the third and the fourth paragraph of Article 31);
6. for failing to carry out the procedure for assessing the system for integral quality assurance or the procedure for assessing the production quality assurance system (the first paragraph of Article 32);
7. for failing to issue a written declaration, keeping it for five years or failing to make it available to the body competent for medical devices (the second paragraph of Article 32);
8. for failing to attach to the medical device the prescribed information or attaching or indicating them contrary to Article 33 hereof or on the basis of this Act and the related implementing regulations;
9. for failing to attach to the medical device the instructions for use contrary to the fifth paragraph of Article 33 of this Act or the implementing regulations issued on its basis;
10. for failing to notify the changes to clinical investigation in accordance with Article 41 hereof;
11. for failing to inform the body competent for medical devices of the discontinuation of a clinical investigation (the third paragraph of Article 42);
12. for failing to inform the body competent for medical devices of the discontinuation of a clinical investigation within the prescribed deadline or failing to send it the final report (Article 43);
13. for failing to communicate changes to data in accordance with Article 46 hereof;
14. for failing to register in the register of the manufacturers of medical devices or communicate changes to data in accordance with Article 47 hereof;
15. for failing to meet the obligations that apply to manufacturers of medical devices in accordance with the first paragraph of Article 48 hereof;
16. for failing to notify medical devices, as manufacturer, in accordance with Article 49 hereof;
17. for failing to communicate changes to data, as manufacturer in accordance with the third paragraph of Article 50 hereof;
18. for failing to notify itself to the body competent for medical devices for registration in the register of legal entities engaged in wholesaling medical devices of failing to communicate changes to data (the second and the sixth paragraph of Article 52 hereof);
19. for failing to notify itself to the body competent for medical devices for registration in the register of specialised stores engaged in retailing medical devices of failing to communicate changes to data pursuant to the fifth paragraph of Article 53 hereof;
20. for retailing medical devices contrary to Article 53 hereof;
21. for failing to inform the body competent for medical devices of a complication related to a medical device (the third paragraph of Article 56);
22. for failing to keep a list of persons in accordance with Article 56 hereof.
(2) A fine from 500 to 5,000 euros shall be imposed for an offence listed in the previous paragraph on an independent sole proprietor and an individual engaging in a registered activity.
(3) A fine from 200 to 2,000 euros shall be imposed on the responsible person of the legal entity or the responsible person of an individual sole proprietor for committing the offence referred to in the first paragraph hereunder.
 

Article 67
(Penal provisions)
(1) A fine from 15,000 to 150,000 euros shall be imposed for an offence on a legal entity that:
1. puts on the market or into use medical devices that are not compliant with the requirements hereof (the first paragraph of Article 19);
2. fails to produce an EC declaration of conformity in accordance with the sixth paragraph of Article 23 hereof;
3. fails to affix a CE marking in accordance with the sixth paragraph of Article 23 hereof;
4. affixes a CE marking to a product that is not a medical device (the first paragraph of Article 30);
5. affixes a CE marking to a medical device that is incompliant with this Act or affixes it contrary to the provisions of this Act (the second and the third paragraph of Article 30);
6. affixes a marking or inscription similar to the CE marking which is misleading as to the meaning or graphic representation of the CE marking (the fourth paragraph of Article 30);
7. covers the CE marking by affixing to a medical device, packaging or instructions for use any other label or causing ambiguity as to the labelling (the fifth paragraph of Article 30);
8. performs the tasks of a notified body without being appointed and notified as such in accordance with the first paragraph of Article 34 hereof;
9. fails to inform the body competent for medical devices of, or submit to it, the relevant EC certificates in accordance with the fourth paragraph of Article 37 hereof;
10. fails to inform the body competent for medical devices of the relevant EC certificates in accordance with the fifth paragraph of Article 37 hereof;
11. commences a clinical investigation even though the conditions from Article 39 hereof or the implementing regulations issued on the basis of this Act have not been met;
12. carries out a clinical investigation contrary to this Act and regulations issued on the basis of this Act,
13. no longer meets the requirements from Article 44 hereof;
14. fails to enter itself in the register of manufacturers of medical devices (the first paragraph of Article 45);
15. fails to meet the conditions or obligations laid down in the third, fourth and fifth paragraph of Article 52 hereof;
16. retails in vitro diagnostic medical devices for HIV self-testing outside a pharmacy (the third paragraph of Article 53);
17. retails medical devices without adequately qualified and trained personnel for professional consulting (the fourth paragraph of Article 53);
18. markets medical devices contrary to the seventh paragraph of Article 53 hereof;
19. fails to meet the conditions laid down in the third and fourth paragraph of Article 54 hereof;
20. fails to notify itself with the body competent for medical devices in accordance with the fifth or sixth paragraph of Article 54 hereof;
21. blocks free movement of medical devices (Article 55);
22. fails to meet the obligations from the sixth paragraph of Article 56 hereof;
23. advertises a medical device contrary to the first or third paragraph of Article 58 hereof;
24. advertises a medical device with information from the first paragraph of Article 59 hereof;
25. gives, offers or promises gifts, pecuniary advantages or benefits in kind to the expert public when advertising medical devices unless they are of small value (the second paragraph of Article 59);
26. presents the characteristics and purpose of use of medical devices in a misleading way (the third paragraph of Article 59);
27. gives samples of medical devices contrary to the fourth paragraph of Article 59 hereof;
28. puts on the market or into use any products presented with the characteristics of a medical device not classified as such pursuant to this Act (Article 60).
(2) A fine from 700 to 7,000 euros shall be imposed for an offence listed in the previous paragraph on an independent sole proprietor and an individual engaging in a registered activity.
(3) A fine from 300 to 3,000 euros shall be imposed on the responsible person of the legal entity or the responsible person of an individual sole proprietor for committing the offence referred to in the first paragraph hereunder.
 

XVI. TRANSITIONAL AND FINAL PROVISIONS
Article 68
(Issue of implementing regulations)
(1) The implementing regulations based on this Act shall be issued before the beginning of application hereof.
(2) Until the beginning of application of this Act, the implementing regulations issued on the basis of the Medical Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – Zkrmi, 67/02, 47/04 – ZdZPZ and 31/06 – ZZdr-1) shall apply, provided that they are not contrary to this Act or unless otherwise stipulated hereby:
- Rules concerning the requirements to be met by specialized retail traders in medical devices (Official Gazette of the RS, no. 73/00);
- Rules on medical devices (Official Gazette of the Republic of Slovenia, nos. 71/03, 51/04 and 98/06);
- Rules on in vitro diagnostic medical devices (Official Gazette of the Republic of Slovenia, nos. 47/02, 75/03 and 51/04);
- Rules on the advertising of medicinal products and medical devices (Official Gazette of the Republic of Slovenia, nos. 76/01 and 105/08).
 

Article 69
(Procedures following the enforcement of this Act)
(1) Medical devices the manufacturers or representatives of which have their registered offices in the Republic of Slovenia and which are available on the market on the date of the beginning of the application of this Act shall be entered in the register of medical devices in accordance herewith until 21 September 2010.
(2) As of the beginning of application of this Act, the registers established on the basis of the Medical Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – Zkrmi, 67/02, 47/04 – ZdZPZ and 31/06 – ZZdr-1) shall be kept as registers hereunder and their contents must be aligned with the provisions hereof until 21 September 2010.
(3) The notified body appointed before the beginning of application hereof must be appointed hereunder by no later than 21 September 2010.
 

Article 70
(Procedures prior to the enforcement of this Act)
Procedures initiated prior to the enforcement of this Act shall be finished pursuant to the provisions stipulated hereby.
 

Article 71
(Abrogation)
On the day this Act enters into force, the Medical Devices Act (Official Gazette of the Republic of Slovenia nos. 101/99, 70/00, 7/02, 13/02 – ZKrmi, 67/02 and 47/04 – ZdZPZ and 31/06 – ZZdr-1) which applies until the enforcement of this Act, shall cease to apply.
 

Article 72
(Enforcement and beginning of application of this Act)
This Act shall enter into force on the fifteenth day of its publication in the Official Gazette of the Republic of Slovenia and shall apply as of 21 March 2010.