- What is a medical device?
- diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease,
- diagnosis, monitoring, treatment, alleviation of, or compensation for, an injury or disability,
- investigation, replacement or modification of the anatomy or of a physiological or pathological process or state,
- providing information by means of in vitro examination of specimens derived from the human body, including organ, blood and tissue donations,
and which does not achieve its principal intended action by pharmacological, immunological or metabolic means, in or on the human body, but which may be assisted in its function by such means.
- What else is deemed to be a medical device?
- devices for the control or support of conception,
- products specifically intended for the cleaning, disinfection or sterilisation of devices,
- accessories for medical devices,
- products listed in Annex XVI (product without an intended medical purpose).
- What is an accessory for a medical device?
“Accessory for a medical device” means an article which, whilst not being itself a medical device, is intended by its manufacturer to be used together with one or several particular medical device(s) to specifically enable the medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the medical device(s) in terms of its/their intended purpose(s).
- What is an in vitro diagnostic medical device?
- Concerning a physiological or pathological process or state;
- Concerning congenital physical or mental impairments;
- Concerning the predisposition to a medical condition or a disease;
- To determine the safety and compatibility with potential recipients;
- To predict treatment response or reactions;
- To define or monitoring therapeutic measures.
Specimen receptacles shall also be deemed to be in vitro diagnostic medical devices. “Specimen receptacle” means a device, whether of a vacuum-type or not, specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination.
- What are accessories for in vitro diagnostic medical devices?
The IVDR also regulates accessories for in vitro diagnostic medical devices, devices for self-test, devices for near-patient testing and companion diagnostics.
Accessory for an in vitro diagnostic medical device means an article which, whilst not being itself an in vitro diagnostic medical device, is intended by its manufacturer to be used together with one or several particular in vitro diagnostic medical device(s) to specifically enable the in vitro diagnostic medical device(s) to be used in accordance with its/their intended purpose(s) or to specifically and directly assist the medical functionality of the in vitro diagnostic medical device(s) in terms of its/their intended purpose(s).
- What is a device for self-testing?
Device for self-testing means any device intended by the manufacturer to be used by lay persons, including devices used for testing services offered to lay persons by means of information society services.
Device for near-patient testing means any device that is not intended for self-testing but is intended to perform testing outside a laboratory environment, generally near to, or at the side of, the patient by a health professional.
- What does companion diagnostic mean?
- identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or
- identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product.
- Which legislation governs the medical devices sector?
- Regulation (EU) 2017/745 of the European Parliament and of the Council on medical devices – MDR
- Regulation (EU) 2017/746 on in vitro diagnostic medical devices – IVDR
Date of application:
MDR: 26 May 2021
IVDR: 26 May 2022
Extensive information is published on the website of the European Commission. On the same page under the GUIDANCE tab, the guidance adopted by the Medical Device Coordination Group (MDCG) that helps stakeholders in implementing both relevant EU Regulations’ provisions can be accessed.
- What about national legislation?
As of 19 June 2025, the Medical Devices Act (ZMedPri-1, Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25) has been in force. It governs the medical devices sector, including accessories for medical devices, devices without an intended medical purpose and in vitro diagnostic medical devices.
The Medical Devices Act (ZMedPri-1) regulates at national level the competent authorities for the implementation of Regulation (EU) 2017/745, Regulation (EU) 2017/746 and Regulation (EU) 2022/123, the language requirements, the reprocessing and further use of single-use devices, the establishment of the JAZMP information system, the conditions applicable to distributors of medical devices, the exceptional authorisation for placing devices on the market, the information to be provided to patients who have been implanted with a device and the information to be kept by health institutions, the enabling of the provision of information to laypersons, advertising, the registration of economic operators and devices, clinical investigations and performance studies, cooperation between the National Medical Ethics Committee and JAZMP, vigilance, fees and offences and penalties for breaches of the provisions of Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2022/123 and this Act.
- What are the transitional provisions under the MDR and IVDR and what is the validity of certificates?
Further information is available at:
https://www.jazmp.si/medicinski-pripomocki/splosno-o-medicinskih-pripomockih/novi-uredbi-mdr-in-ivdr/
- What does a custom-made device mean?
“Custom-made device” means any device specifically made in accordance with a written prescription of any person authorised by national law by virtue of that person’s professional qualifications which gives, under that person’s responsibility, specific design characteristics, and is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs.
However, mass-produced devices which need to be adapted to meet the specific requirements of any professional user and devices which are mass-produced by means of industrial manufacturing processes in accordance with the written prescriptions of any authorised representative shall not be considered to be custom-made devices.
Link to MDCG 2021-3 – “Questions and Answers on Custom-Made Devices”:
https://health.ec.europa.eu/system/files/2021-03/mdcg_2021-3_en_0.pdf
- What does an active device mean?
“Active device” means any device, the operation of which depends on a source of energy other than that generated by the human body for that purpose, or by gravity, and which acts by changing the density of or converting that energy. Devices intended to transmit energy, substances or other elements between an active device and the patient, without any significant change, shall not be deemed to be active devices.
Software shall also be deemed to be an active device.
- What does an implantable device mean?
“Implantable device” means any device, including those that are partially or wholly absorbed, which is intended: – to be totally introduced into the human body, or – to replace an epithelial surface or the surface of the eye, by clinical intervention and which is intended to remain in place after the procedure. Any device intended to be partially introduced into the human body by clinical intervention and intended to remain in place after the procedure for at least 30 days shall also be deemed to be an implantable device.
- What is the role of JAZMP in the medical devices sector?
- Maintaining the registers of economic operators established in the Republic of Slovenia who carry out activities in the medical devices sector;
- Maintaining the register of medical devices of manufacturers and authorised representatives established in the Republic of Slovenia;
- Issuing certificates of free sale;
- Conducting the procedures for the approval and assessment of applications for clinical investigations and performance studies;
- Carrying out vigilance procedures and publishing on its website, on a monthly basis, the notifications of field safety corrective actions received;
- Maintaining the list of devices whose availability economic operators may ensure without professional advice;
- Handling notifications of the interruption or discontinuation of supply of devices, in accordance with Article 10(a) of the MDR and the IVDR as introduced by Regulation (EU) 2024/1860;
- Carrying out supervision of the implementation of Regulation (EU) 2017/745, Regulation (EU) 2017/746, Regulation (EU) 2022/123 and the national act, including, for example, verifying the compliance of devices placed on the Slovenian market and the fulfilment of conditions and obligations by Slovenian economic operators;
- Carrying out authorisation procedures for placing on the market or putting into service, pursuant to Article 59 of the MDR and Article 54 of the IVDR;
- Appointing and supervising the notified bodies in the Republic of Slovenia;
- Participating in international EU coordination and working groups;
- Participating in umbrella EU groups such as: MDCG, CAMD, HMA Core Group, Medical Devices Committee.
- Which economic operators are defined by the two EU Regulations?
“Manufacturer” means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trademark.
“Authorised representative” means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer, located outside the European Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation.
“Importer” means any natural or legal person established within the European Union that places a device from a third country on the European Union market.
“Distributor” means any natural or legal person in the supply chain, other than the manufacturer or the importer, that makes a device available on the market, up until the point of putting into service.
“System or procedure pack producer” in accordance with Article 22 of the MDR – combining CE-marked devices with other products in a manner that is compatible with the intended purpose of the devices and within the limits of use specified by their manufacturers (preparation of the required statement).
“Health institution” means an organisation the primary purpose of which is the care or treatment of patients or the promotion of public health.
- Who is responsible for determining whether a product qualifies as a medical device and for its classification?
The manufacturer is responsible for deciding whether a product falls within the scope of medical devices and for determining its classification.
In accordance with Regulation (EU) 2017/745, devices are classified into different risk classes for the user. For the lowest risk class, class I, the manufacturer prepares an EU Declaration of Conformity by which it ensures that the device is safe, compliant and effective. For the other device risk classes (class I – sterile, class I – with a measuring function, class IIa, class IIb and class III), the manufacturer must involve a notified body in the conformity assessment, which, upon completion of the assessment, issues the EU certificate. In addition to the CE marking, such a device bears the four-digit identification number of the notified body that carried out the assessment.
Regulation (EU) 2017/746 completely changes the classification of in vitro diagnostic medical devices and divides them into risk classes: A, A sterile, B, C and D. For the lowest risk class, class A, the manufacturer prepares an EU Declaration of Conformity by which it ensures that the device is safe, compliant and effective. For other risk classes of the device (Class A – sterile, B, C and D), the manufacturer must involve a notified body in the conformity assessment, followed by the issuance of an EU certificate at the end of the assessment. In addition to the CE marking, such a device also bears the four-digit identification number of the notified body that carried out the assessment.
It is also important that, in order to meet the obligations of Regulation (EU) 2017/746, most in vitro diagnostic medical devices will require the involvement of a notified body in the conformity assessment and, consequently, the issuing of an EU certificate. The change in classification is shown in the image below:
- What are the legal obligations of economic operators?
Registration of an economic operator in the activity registers: Economic operators established in the Republic of Slovenia that place medical devices on the market, put them into service, make them available on the market, or act as authorised representatives of manufacturers established in third countries are required to register with the JAZMP prior to commencing their activities.
Registration of a medical device in the register of medical devices of the Republic of Slovenia: The obligation to register a medical device applies to manufacturers established in the Republic of Slovenia and to authorised representatives established in the Republic of Slovenia who have been appointed by a third-country manufacturer.
- What are the legal obligations of manufacturers and manufacturer’s authorised representative regarding the registration of medical devices?
In accordance with the transitional provisions of both Regulations (Article 123(3) of the MDR and Article 113(3) of the IVDR), until the EUDAMED database becomes fully applicable, a manufacturer established in the Republic of Slovenia or an authorised representative of a manufacturer established in the Republic of Slovenia must, before placing on the market a device that is not a custom-made device, submit to JAZMP an application for the registration of the device in accordance with Article 45 of the Medical Devices Act – ZMedPri-1 (Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25).
Instructions, guidance and access to the forms are available on the JAZMP website at: https://www.jazmp.si/medicinski-pripomocki/registracija-medicinskih-pripomockov/.
- Definitions
“Making available” means any supply of a device, other than an investigational device, for distribution, consumption or use on the European Union market.
“Placing on the market” means the first making available of a device, other than an investigational device, on the European Union market.
“Putting into service” means the stage at which a device, other than an investigational 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.
- Where do specialised shops fall within the regulatory framework?
The EU Regulations no longer distinguish between wholesale and retail sale. All specialised shops assume the responsibilities of either distributors or importers.
- What information must be indicated on the device packaging and which entities must be identified?
The detailed instructions regarding device labelling are set out in Annex I (General Safety and Performance Requirements) to both Regulations.
The symbols on the device packaging must comply with SIST EN ISO 15223-1:2021.
- What are the obligations of distributors and what must a distributor verify before making a device available on the market?
The obligations of distributors are set out in Article 14 of the MDR and Article 14 of the IVDR.
- The device bears the CE marking and is accompanied by an EU Declaration of Conformity and, for higher risk classes, by a certificate issued by a notified body;
- The device is accompanied by the relevant information provided by the manufacturer (requirements of Annex I, point 23 of the MDR), and the information on the label is indelible, legible and clearly understandable to the intended user or patient,
- The importer has fulfilled the requirements of Article 13(3) of the MDR – indication of the importer’s name, place of business etc.,
- The manufacturer has assigned the UDI where applicable.
- Ensuring that, while the device is under their responsibility, the storage and transport conditions comply with the conditions set by the manufacturer;
- Informing the competent authorities (i.e. the JAZMP in the Republic of Slovenia) when they consider or suspect that a device presents a serious risk, including an indication of any non-compliance and of any corrective action taken;
- Cooperating with the manufacturer, and where necessary also with the authorised representative and the importer, as well as with the competent authorities, when the device is suspected to be non-compliant;
- Forwarding complaints or reports from healthcare professionals, patients or users about suspected incidents related to a device to the manufacturer and, where applicable, the manufacturer’s authorised representative, or the importer;
- Keeping a register of complaints, of non-conforming devices and of recalls and withdrawals;
- Cooperating with the competent authority regarding the demonstration of the device’s compliance;
- Distributors shall cooperate with competent authorities, at their request, on any action taken to eliminate the risks posed by devices which they have made available on the market; Providing, upon request by a competent authority, free samples of the device or, where that is impracticable, granting access to the device;
- Cooperating with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.
The obligations of distributors are also set out in the Distributors’ Handbook, which is published on the JAZMP website under the “Registration of Economic operators” tab. The handbook summarises the requirements of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). To meet the requirements of national legislation, the provisions of the Medical Devices Act (ZMedPri-1, Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25) must be complied with.
The MDCG 2021-27 guidance – “Questions and Answers on Article 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746” – provides additional clarification regarding the obligations of importers and distributors.
- What are the obligations of importers?
The obligations of importers are set out in Article 13 of the MDR and the IVDR.
- the device has been CE marked and that the EU declaration of conformity of the device has been drawn up;
- a manufacturer is identified and that an authorised representative in accordance with Article 11 has been designated by the manufacturer;
- the device is labelled in accordance with this Regulation and accompanied by the required instructions for use;
- where applicable, a UDI has been assigned by the manufacturer in accordance with Article 27.
- Importers must indicate on the device or on its packaging or in a document accompanying the device their name, registered trade name or registered trade mark, their registered place of business and the address at which they can be contacted, so that their location can be established.
- They must ensure that any additional label does not obscure any information on the label provided by the manufacturer.
- Importers shall ensure that, while a device is under their responsibility, storage or transport conditions do not jeopardise its compliance with the general safety and performance requirements set out in Annex I and shall comply with the conditions set by the manufacturer, where available.
- They must inform the competent authorities (i.e. the JAZMP in the Republic of Slovenia) when they consider or suspect that a device presents a serious risk, including an indication of any non-compliance and of any corrective action taken.
- Importers must keep a register of complaints, of non-conforming devices and of recalls and withdrawals, and provide the manufacturer, authorised representative and distributors with any information requested by them, in order to allow them to investigate complaints.
- They must cooperate with the competent authority regarding the demonstration of the device’s compliance.
- Importers must cooperate with the competent authorities, at their request, on any action taken to eliminate or, where that is not possible, to mitigate the risks posed by devices which they have placed on the market. They must provide, upon request by a competent authority, free samples of the device or, where that is impracticable, granting access to the device.
- Importers must, for the period referred to in Article 10(8), keep a copy of the EU declaration of conformity and, if applicable, a copy of any relevant certificate, including any amendments and supplements, issued in accordance with Article 56.
- They must cooperate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.
To meet the requirements of national legislation, the provisions of the Medical Devices Act (ZMedPri-1, Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25) must be complied with.
The MDCG 2021-27 guidance – “Questions and Answers on Article 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746” – provides additional clarification regarding the obligations of importers and distributors.
- In which cases do the obligations of manufacturers apply to importers, distributors or other persons?
In accordance with Article 16 of the MDR, a distributor, importer or other natural or legal person shall assume the obligations incumbent on manufacturers if it does any of the following:
(a) Makes available on the market a device under its name, registered trade name or registered trade mark, except in cases where a distributor or importer enters into an agreement with a manufacturer whereby the manufacturer is identified as such on the label and is responsible for meeting the requirements placed on manufacturers in this Regulation;
(b) Changes the intended purpose of a device already placed on the market or put into service;
(c) Modifies a device already placed on the market or put into service in such a way that compliance with the applicable requirements may be affected.
The first subparagraph shall not apply to any person who, while not considered a manufacturer as defined in Article 2(30), assembles or adapts for an individual patient a device already on the market without changing its intended purpose.
- What obligations apply to an economic operator placing a relabelled or repackaged device on the market?
At least 28 days prior to making the relabelled or repackaged device available on the market, distributors or importers carrying out any of the activities mentioned in Article 16(2)(a) and (b) shall inform the manufacturer and the competent authority of the Member State in which they plan to make the device available of the intention to make the relabelled or repackaged device available and, upon request, shall provide the manufacturer and the competent authority with a sample or mock-up of the relabelled or repackaged device, including any translated label and instructions for use. Within the same period of 28 days, the distributor or importer shall submit to the competent authority a certificate, issued by a notified body designated for the type of devices that are subject to activities mentioned in paragraph 2(a) and (b), attesting that the quality management system of the distributer or importer complies with the requirements laid down in paragraph 3.
The European Commission has published the MDCG 2021-26 guidance – “Questions and Answers on repackaging & relabelling activities under Article 16 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746”.
- How is the person responsible for regulatory compliance defined under the Regulations, and what requirements must this person meet?
Manufacturers shall have available within their organisation at least one person responsible for regulatory compliance who possesses the requisite expertise in the field of medical devices (Article 15 of Regulation (EU) 2017/745 and of Regulation (EU) 2017/746).
The requisite expertise shall be demonstrated by either of the following qualifications:
(a) A diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognised as equivalent by the Member State concerned, in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices;
(b) Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
Without prejudice to national provisions regarding professional qualifications, manufacturers of custom-made devices may demonstrate the requisite expertise referred to in the first subparagraph by having at least two years of professional experience within a relevant field of manufacturing.
In accordance with Article 20 of the Medical Devices Act (ZMedPri-1), manufacturers, manufacturer’s authorised representatives, manufacturers of custom-made devices and manufacturers of systems and procedure packs under Article 22 of Regulation (EU) 2017/745 shall, when registering with JAZMP, submit evidence demonstrating the adequacy of the qualifications of the person responsible for regulatory compliance.
Micro and small enterprises within the meaning of Commission Recommendation 2003/361/EC shall not be required to have the person responsible for regulatory compliance within their organisation but shall have such person permanently and continuously at their disposal.
- What are the responsibilities of the person responsible for regulatory compliance?
The person responsible for regulatory compliance (MDR and IVDR) shall at least be responsible for ensuring that:
(a) the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;
(b) the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;
(c) the post-market surveillance obligations are complied with in accordance with Article 10(10) of the MDR and Article 10(9) of the IVDR;
(d) the reporting obligations referred to in Articles 87 to 91 of the MDR and Articles 82 to 86 of the IVDR are fulfilled;
(e) in the case of investigational devices, the statement referred to in Section 4.1 of Chapter II of Annex XV to MDR is issued;
(f) in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects, the statement referred to in Section 4.1 of Annex XIV to IVDR is issued.
- Who prepares the EU Declaration of Conformity?
The EU Declaration of Conformity is drawn up by the device manufacturer in accordance with Annex IV (EU Declaration of Conformity) to both Regulations. The declaration must include all the elements required under that Annex. By drawing up the EU Declaration of Conformity, the manufacturer assumes responsibility for compliance with the requirements of this Regulation and with all other Union legislation applicable to the device. The manufacturer shall continuously update the EU declaration of conformity.
- How are the Unique Device Identification, the Basic UDI-DI and the UDI-DI system defined under the Regulations and what advantages do they provide?
Further information is available at:
https://www.jazmp.si/medicinski-pripomocki/splosno-o-medicinskih-pripomockih/mdcg-smernice-za-medicinske-pripomocke/edinstveni-identifikator-pripomocka-udi/
- Is it necessary to affix the UDI to the device packaging when the device is placed on the market?
A transitional period for affixing the UDI to the device packaging is laid down, as shown in the illustration:
- What format can the UDI carrier on the device take?
The format of the UDI carrier on the device is determined by the manufacturer together with the UDI issuing entity. The carrier may take several formats: a linear barcode, a QR code, RFID or a matrix code:
- Which entities are designated as UDI issuing entities under the Regulation?
The issuing entities are listed in Article 120(12) of the MDR. These are GS1, HIBCC, ICCBBA and IFA.
Each issuing entity has its own specific method for issuing UDIs, which is described on the following website:
- What are the obligations of health institutions?
- the patient’s identification number in the CRPP,
- the personal name of the patient,
- the health institution number, the name and address of the healthcare institution, the institution’s contact details,
- the date of implantation of the device,
- information enabling the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and the website of the manufacturer (the data referred to in Article 18(1)(a) of Regulation (EU) 2017/745).
In the event of a safety risk related to implanted devices, JAZMP may require health institutions or the National Institute of Public Health to provide data on the number and type of each device that has been implanted. Health institutions and the National Institute of Public Health must respond immediately and no later than three days after receiving the request from JAZMP.
Health institutions store and retain, preferably in electronic form, the UDIs for the devices which they have supplied or which have been supplied to them, where these devices fall within class III implantable devices (Article 27(9) of the MDR and Article 24 of the IVDR). In accordance with Article 12 of the Medical Devices Act (ZMedPri-1), health institutions keep records in the same manner also for the devices for which a notified body has issued a certificate and which they own. Health institutions must establish the device register by 19 June 2026. Economic operators that use devices in the course of their activities maintain the devices in accordance with the manufacturer’s instructions.
In accordance with Article 20 of the Medical Devices Act (ZMedPri-1), health institutions have within their organisation at least one person responsible for regulatory compliance and at least one person responsible for reporting vigilance incidents. The tasks of the person responsible for regulatory compliance may also be performed by the person responsible for vigilance reporting. In addition to the obligations laid down in Article 14(2) of Regulation (EU) 2017/745 and Article 14(2) of Regulation (EU) 2017/746, the person responsible for regulatory compliance keeps a record of the tasks carried out, which provides the basis for demonstrating the fulfilment of their obligations. The persons referred to in the first sentence of this paragraph must have appropriate expertise in the field of medical devices, demonstrated by a certificate issued by an economic operator in the field of devices confirming at least one year of professional experience with regulatory requirements or a quality management system related to medical devices, or by a copy of the contract or another relevant document.
In accordance with Article 17 of the Medical Devices Act (ZMedPri-1), health institutions that carry out the reprocessing of single-use devices (hereinafter: device reprocessors) must, in accordance with Article 14 of this Act, register in the JAZMP information system before commencing this activity.
In accordance with Article 18 of the Medical Devices Act (ZMedPri-1), health institutions that manufacture and use devices in accordance with Article 5(5) of Regulation (EU) 2017/745, Article 5(5) of Regulation (EU) 2017/746 and Article 13 of this Act must register in the JAZMP information system before commencing this activity.
In accordance with Article 30 of the Medical Devices Act (ZMedPri-1), a health institution grants an economic operator access to the device for the purpose of an investigation related to a serious incident involving the device which is suspected to have occurred and which has been reported. If this is not possible, the health institution shall provide a sample of an identical device.
- What is EUDAMED, how is it structured and what is its purpose?
Further information is available at:
https://www.jazmp.si/medicinski-pripomocki/splosno-o-medicinskih-pripomockih/eudamed/
- Is registration in EUDAMED mandatory?
Currently, registration in EUDAMED is not yet mandatory. Registration in EUDAMED shall become mandatory six months after the publication in the Official Journal of the European Union of a notice stating that one or more electronic systems (modules) are operational and comply with the functional specifications.
The European Commission and JAZMP already encourage all economic operators to register in EUDAMED.
- Which economic operators register in EUDAMED and which register in the national register maintained by JAZMP?
Manufacturers, manufacturer’s authorised representatives, importers and manufacturers of systems and procedure packs register in EUDAMED (Article 22 of the MDR).
Until EUDAMED is fully functional, all economic operators established in the Republic of Slovenia are required to register in the national register maintained by JAZMP, namely manufacturers, authorised representatives, distributors, importers and manufacturers of custom-made devices.
After EUDAMED becomes fully functional, distributors, manufacturers of custom-made medical devices, device reprocessors and health institutions that manufacture and use devices within health institutions are required to register in the national register maintained by JAZMP.
- How is the registration of an economic operator in EUDAMED carried out and what is the procedure for obtaining the single registration number of the economic operator?
Economic operators enter in EUDAMED the information set out in Section 1 of Part A of Annex VI to the MDR and the IVDR. After verification of the data, the competent authority for medical devices (i.e. JAZMP in the Republic of Slovenia) assigns a single registration number (SRN) to the economic operator, which appears as shown in the illustration below:
The manufacturer is required to use the single registration number when submitting an application for conformity assessment to a notified body and when accessing EUDAMED in order to fulfil its obligations under Article 29 of the MDR and Article 26 of the IVDR.
- Are pharmacies also required to register in the national register maintained by JAZMP?
Pharmacies are also required to register in the national register, namely as distributors, provided that they do not import devices. Under the new Regulation, pharmacies assume the obligations of distributors and are required to comply with all provisions applicable to distributors.
- What are the requirements for distance sales?
Distance sales are defined in Article 6 of the MDR, which provides that a device made available to a natural or legal person established in the European Union through information society services, as defined in Article 1(1)(b) of Directive 2015/1535, is required to comply with the MDR or the IVDR.
- How is the registration of an economic operator established in the Republic of Slovenia carried out?
The registration of an economic operator is done via the Slovenian Business Point (SPOT) portal. The application for registration may be submitted by any natural person who is authorised by the respective economic operator to submit the application and holds a qualified digital certificate.
The instructions for completing the application are available at the following link:
https://spot.gov.si/assets/Navodila/Navodila-JAZMP.pdf
- How is the registration of a business/economic operator established in the Republic of Slovenia carried out if the company does NOT hold a qualified digital certificate?
The instructions are available at the following link:
https://www.jazmp.si/medicinski-pripomocki/registracija-poslovnih-subjektov/
- How is the registration of a medical device carried out in the Republic of Slovenia?
The instructions are available at the following link:
https://www.jazmp.si/medicinski-pripomocki/registracija-medicinskih-pripomockov/
- Are opticians considered manufacturers of medical devices?
The vast majority of opticians/eye care practices, in accordance with the definition of a custom-made device and the MDCG Guidance MDCG 2021-3 Questions and Answers on Custom-Made Devices, no longer consider such devices to fall under custom-made devices. Instead, these economic operators are classified as distributors or importers. These operators shall comply with the provisions of Article 13 or Article 14 of the MDR.
The guidance clarifies the differences between custom-made devices, patient-matched medical devices and adaptable medical devices.
Corrective spectacles assembled by adjusting individual components (frames, lenses) are in most cases not custom-made devices within the meaning of the MDR definition, but merely devices that have been adapted in accordance with the manufacturer’s instructions.
- How is the procedure for obtaining a Certificate of Free Sale carried out?
The instructions are available at the following link:
https://www.jazmp.si/medicinski-pripomocki/certifikat-o-prosti-prodaji
- In which language must the instructions for use of a medical device be written?
In accordance with Article 7 of the Medical Devices Act (ZMedPri-1), the labels and the instructions for use referred to in Section 23 of Annex I to Regulation (EU) 2017/745 and Section 20 of Annex I to Regulation (EU) 2017/746 which are intended for the lay person, including the information referred to in Article 18(1) of Regulation (EU) 2017/745 (the implant card and the information for patients with an implanted device), shall be provided in the Slovenian language.
The labels and the instructions for use for devices designated by the manufacturer for professional use are to be provided in the Slovenian language or in another language understandable to the user. If the instructions for use are not provided in the Slovenian language, the economic operator supplying the device to the health institution must, at the request of the health institution, immediately and no later than ten days after the request, provide the instructions for use in the Slovenian language.
- Must the instructions for use be included in the sales packaging of the medical device?
The instructions for use are to be included in the sales packaging of the medical device, except for class I and class IIa medical devices where safe use is possible without instructions for use. However, information on the medical device is to be provided to the user upon request.
In duly justified and exceptional cases, the instructions for use for in vitro diagnostic medical devices are not required or may be provided in a shortened form, provided that the device can be used safely and as intended by the manufacturer without such instructions for use. If an in vitro diagnostic medical device is intended solely for professional use, the instructions for use may be provided to the user in a non-paper format (e.g. electronic), unless the device is intended for near-patient testing. If the instructions for use are not provided in paper form, the device label is to indicate the availability of such instructions and, where appropriate, the website address at which they are available.
- What information must the implant card contain?
In accordance with Article 18 of the MDR, the implant card provided by the manufacturer is to contain information allowing the identification of the device, including the device name, serial number, lot number, the UDI, the device model, as well as the name, address and website of the manufacturer.
It is to contain all warnings, precautions or measures to be taken by the patient or a healthcare professional with regard to reciprocal interference with reasonably foreseeable external influences, medical examinations or environmental conditions.
It is also to contain all information on the expected lifetime of the device and any necessary follow-up, as well as any other information required to ensure the safe use of the device by the patient, including the information referred to in Section 23.4(u) of Annex I.
Further information and the prescribed format of the implant card are set out in two guidance documents:
MDCG 2021-11 – “Guidance on Implant Card in – Device types”
MDCG 2019-8 v2 – Implant Card relating to the application of Article 18 Regulation (EU) 2017/745
The layout of the card is presented in the illustrations below. The first part of the data on the implant card is pre-filled by the manufacturer, while the second part containing the patient data is completed by the health institution.
- What is the procedure for placing a device on the market under exceptional circumstances and what are the obligations of economic operators?
By way of derogation from Article 52 of the MDR and Article 48 of the IVDR, any competent authority may authorise, on a duly justified request, the placing on the market or putting into service within the territory of the Member State concerned, of a specific device for which the procedures referred to in the aforementioned Articles have not been carried out but use of the device is in the interest of public health or patient safety or health.
The entire procedure for submitting the application and the required documentation in the context of the emergency authorisation procedure is available at the following link:
https://www.jazmp.si/medicinski-pripomocki/ostale-regulatorne-zadeve/neskladni-medicinski-pripomocki/
- How should waste in the field of medical devices be managed?
JAZMP has no competence regarding the management of waste arising from medical devices.
In accordance with Regulation (EU) 2017/745 and Regulation (EU) 2017/746, the manufacturer is the natural or legal person who manufactures or fully refurbishes a device or has it designed, manufactured or fully refurbished, and markets that device under its own name or trade mark. It is the manufacturer who, in the instructions for use as well as in the technical documentation, specifies the procedures for handling the waste generated.
The distributor, who makes the device available, likewise has its own obligations. These obligations are set out in Article 14 of both Regulations.
To facilitate understanding, JAZMP has prepared the guidance document for distributors, which is available on the JAZMP website. The Handbook summarises the requirements of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). To meet the requirements of national legislation, the provisions of the Medical Devices Act (ZMedPri-1, Official Gazette of the Republic of Slovenia [Uradni list RS], No 40/25) must be complied with.
- What is the definition of a clinical investigation in accordance with the MDR?
The clinical investigation of a medical device is any systematic investigation involving one or more human subjects, undertaken to assess the safety or performance of a device. It should be noted that this definition includes the use of both non-CE marked and CE marked devices.
Further information on clinical investigations is available at the following link:
- How is the notification procedure for a clinical investigation carried out?
The notification procedure for a clinical investigation is available at the following link:
https://www.jazmp.si/medicinski-pripomocki/klinicne-raziskave/postopek-priglasitve-pregleda-in-zakljucka-klinicne-raziskave/.
- What is the definition of performance studies in accordance with the IVDR and what is the notification procedure at JAZMP?
A performance study means a study conducted to establish or confirm the analytical or clinical performance of an in vitro diagnostic medical device.
The notification procedure for a performance study is available at the following link:
https://www.jazmp.si/medicinski-pripomocki/studije-ovrednotenja-delovanja/postopek-priglasitve-pregleda-in-zakljucka-studije-ucinkovitosti/.
- How is the vigilance of medical devices defined under the Regulations?
The medical device vigilance system has been set up to protect public health and the health and safety of patients and other users of medical devices through the introduction of field safety corrective actions and the reduction of the possibility of recurrence of a medical device-related incident that has been noted in the past.
Activities performed by the JAZMP in relation to the vigilance system include collecting and evaluating serious incident reports in cooperation with the manufacturer of medical devices or its representative, monitoring the manufacturer or its representative in investigating the incident, implementing any further measures necessary to complement the measures taken by the manufacturer or its representative, and participating in the international medical device vigilance system.
- Which vigilance-related definitions derive from the MDR and the IVDR?
“Incident” means any malfunction or deterioration in the characteristics or performance of a device made available on the market, including use-error due to ergonomic features, any undesirable side effect, any inadequacy in the information supplied by the manufacturer, and any harm that results from a medical decision or action taken or not taken on the basis of information or results provided by the device.
- the death of a patient, user or other person,
- the temporary or permanent serious deterioration of a patient’s, user’s or other person’s state of health,
- a serious public health threat.
“Serious public health threat” means an event which could result in imminent risk of death, serious deterioration in a person’s state of health, or serious illness, that may require prompt remedial action, and that may cause significant morbidity or mortality in humans, or that is unusual or unexpected for the given place and time.
Further information is available at the following link:
https://www.jazmp.si/medicinski-pripomocki/vigilanca-medicinskih-pripomockov/
- Who reports incidents involving medical devices?
Incidents involving medical devices that occur in the territory of the Republic of Slovenia are to be reported to JAZMP by participants in the vigilance system, as described at the following link: https://www.jazmp.si/medicinski-pripomocki/vigilanca-medicinskih-pripomockov/porocanje-o-zapletih/.
For easier and faster reporting of serious incidents by healthcare professionals, users and patients, JAZMP has also prepared an online form, which is available at the following link:
https://www.jazmp.si/medicinski-pripomocki/vigilanca-medicinskih-pripomockov/porocanje-o-resnih-zapletnih-spletni-obrazec/
- In what manner and to whom do healthcare professionals, users and patients report a serious incident?
Incidents involving medical devices that occur in the territory of the Republic of Slovenia are to be reported to JAZMP by participants in the vigilance system, as described at the following link: https://www.jazmp.si/medicinski-pripomocki/vigilanca-medicinskih-pripomockov/porocanje-o-zapletih/.
If a healthcare professional, user or patient contacts the manufacturer or the distributor, it is expected that they inform them of the incident. What is essential, however, is that they enable the return or examination of the device that caused the incident; where the packaging is also available, it is to be provided together with the device.
- In what manner and to whom do manufacturers report a serious incident?
Incidents involving medical devices that occur in the territory of the Republic of Slovenia are to be reported to JAZMP by participants in the vigilance system, as described at the following link: https://www.jazmp.si/medicinski-pripomocki/vigilanca-medicinskih-pripomockov/porocanje-o-zapletih/.
Until the vigilance module in EUDAMED has been established, the manufacturer is required to submit reports of serious incidents that occur in the Republic of Slovenia to JAZMP using the forms published on the relevant JAZMP website.
- In what manner and to whom do distributors/importers report a serious incident?
Distributors and importers who receive complaints or reports of suspected serious incidents related to a device they have made available are required to immediately forward this information to the manufacturer and, where necessary, to the manufacturer’s authorised representative and the importer.
If a distributor or importer considers that a suspected serious incident also represents a serious risk, they are required to notify JAZMP thereof using the form for reporting a detected serious risk, as described at the following link: https://www.jazmp.si/medicinski-pripomocki/vigilanca-medicinskih-pripomockov/porocanje-o-zapletih/.
- Reporting to JAZMP on a serious risk or the occurrence of falsified devices
In the event of a detected serious risk related to a device or a suspicion that a device is falsified, users, patients, healthcare professionals or economic operators are required to report this to JAZMP using the form for reporting a detected serious risk.
- In what manner and to whom do manufacturers report a detected serious risk or the occurrence of falsified or stolen devices?
If a manufacturer considers that a device presents a serious risk or is falsified or stolen, it is required to immediately notify the competent authorities of the Member States in which it has made the device available.
It is required to notify JAZMP using the form for reporting a detected serious risk, indicating in particular details of the non-conformity of the device and any corrective actions taken.
- In what manner and to whom do distributors/importers report a detected serious risk or the occurrence of falsified or stolen devices (non-conformities)?
If a distributor or importer considers that a device presents a serious risk or is falsified or stolen, it is required to immediately notify the manufacturer and the competent authorities of the Member States in which it has made the device available.
It is required to notify JAZMP using the form for reporting a detected serious risk, indicating in particular details of the non-conformity of the device and any corrective actions taken.
- How is the reporting of safety corrective actions to the competent authorities carried out?
The manufacturer of medical devices or the manufacturer’s authorised representative is required to submit reports on field safety corrective actions to all competent authorities of the EU Member States in which the medical device concerned is made available on the market, as well as to the competent authority of the Member State in which the manufacturer or the authorised representative is established.
The reporting instructions are available at the following link:
https://www.jazmp.si/medicinski-pripomocki/vigilanca-medicinskih-pripomockov/
- Who is responsible for informing users through a safety notice (field safety notice)?
The manufacturer is required to ensure that users of the device concerned are immediately informed of the field safety corrective action taken, on the basis of the official field safety notice (safety notice) issued by the manufacturer.
Further information is available at the following link:
https://www.jazmp.si/medicinski-pripomocki/vigilanca-medicinskih-pripomockov/
- What is the role of distributors/importers in the implementation of a field safety corrective action?
Distributors are required to cooperate with the manufacturer and, where necessary, with the manufacturer’s authorised representative and the importer, as well as with the competent authorities, in order to ensure that the necessary corrective actions are taken on the basis of which the device becomes compliant or is withdrawn or recalled from the market, as appropriate.
JAZMP expects distributors and importers to ensure the prompt informing of all parties in their distribution chain and the timely implementation of the corrective action, in accordance with the manufacturer’s instructions set out in the safety notification (field safety notice) issued. Upon request, dated evidence of the informing and of the implementation of the corrective action is to be made available to the competent authorities for inspection.
- Which notified bodies in the EU have already been designated for issuing certificates under the MDR and the IVDR, and where can they be found?
The notified bodies already designated for the certification of devices under the MDR and the IVDR are available at the following link:
https://ec.europa.eu/growth/tools-databases/nando/.
- How is the manufacturer of a system or procedure pack defined under Article 22 in accordance with the MDR?
Natural or legal persons shall draw up a statement if they combine devices bearing a CE marking with the following other devices or products, in a manner that is compatible with the intended purpose of the devices or other products and within the limits of use specified by their manufacturers, in order to place them on the market as a system or procedure pack:
(a) other devices bearing the CE marking;
(b) in vitro diagnostic medical devices bearing the CE marking in conformity with Regulation (EU) 2017/746;
(c) other products which are in conformity with legislation that applies to those products only where they are used within a medical procedure or their presence in the system or procedure pack is otherwise justified.
In the statement made pursuant to paragraph 1, the natural or legal person concerned shall declare that:
(a) they verified the mutual compatibility of the devices and, if applicable other products, in accordance with the manufacturers’ instructions and have carried out their activities in accordance with those instructions;
(b) they packaged the system or procedure pack and supplied relevant information to users incorporating the information to be supplied by the manufacturers of the devices or other products which have been put together;
(c) the activity of combining devices and, if applicable, other products as a system or procedure pack was subject to appropriate methods of internal monitoring, verification and validation.
- How is an in-house device defined in the IVDR and what are the requirements for economic operators?
An in-house device as defined in the IVDR is any IVD medical device or accessory for an IVD medical device that is manufactured and used solely within a particular health institution in accordance with Article 5(5) of the IVDR.
With the exception of the relevant general safety and performance requirements set out in Annex I, the requirements of this Regulation shall not apply to devices, manufactured and used only within health institutions established in the European Union, provided that all of the following conditions are met:
(a) The devices are not transferred to another legal entity;
(b) Manufacture and use of the devices occur under appropriate quality management systems;
(c) The laboratory of the health institution shall meet the requirements of standard EN ISO 15189 or, where applicable, national provisions, including national provisions on accreditation;
(d) The health institution justifies in its documentation that the target patient group’s specific needs cannot be met at the appropriate level of performance by an equivalent device available on the market;
(e) The health institution provides information upon request on the use of such devices to its competent authority, which shall include a justification of their manufacturing, modification and use;
(f) The health institution draws up a declaration which it shall make publicly available, including:
(i) the name and address of the manufacturing health institution;
(ii) the details necessary to identify the devices;
(iii) a declaration that the devices meet the general safety and performance requirements set out in Annex I to this Regulation and, where applicable, information on which requirements are not fully met with a reasoned justification therefor;
(g) as regards class D devices in accordance with the rules set out in Annex VIII, the health institution draws up documentation that makes it possible to have an understanding of the manufacturing facility, the manufacturing process, the design and performance data of the devices, including the intended purpose, and that is sufficiently detailed to enable the competent authority to ascertain that the general safety and performance requirements set out in Annex I to this Regulation are met. Member States may apply this provision also to class A, B or C devices in accordance with the rules set out in Annex VIII;
(h) the health institution takes all necessary measures to ensure that all devices are manufactured in accordance with the documentation referred to in point (g); and
(i) the health institution reviews experience gained from clinical use of the devices and takes all necessary corrective actions.
The national requirements for health institutions that manufacture and use devices within health institutions are laid down in Article 13 of the Medical Devices Act (ZMedPri-1).
For in-house devices manufactured by health institutions for their own use, for which the conditions laid down in Article 5(5) of Regulation (EU) 2017/746 are fulfilled, the health institution is required to publish the declaration on the manufacture and use of in-house devices referred to in Article 5(5)(f) of Regulation (EU) 2017/746 on its website and may additionally publish it on a publicly accessible notice board within the health institution.
For in-house devices, the health institution is required to draw up the documentation referred to in Article 5(5)(g) of Regulation (EU) 2017/746; this obligation applies, in addition to class D, also to in-house devices of classes B and C. The organisational unit of the health institution that manufactures in vitro in-house devices is required to meet at least the requirements of EN ISO 15189.
For the purpose of verifying compliance, JAZMP may require health institutions to provide the documentation referred to in the previous paragraph and the remaining associated documentation. It may request from them the complete documentation on the in-house devices.
Article 18 of the Medical Devices Act (ZMedPri-1) lays down the registration of health institutions that manufacture in-house devices.
- What are the products listed in Annex XVI?
These are products without an intended medical purpose which are nonetheless considered to be medical devices.
They are to be manufactured in accordance with the common specifications, which are available at the following link: https://health.ec.europa.eu/medical-devices-sector/new-regulations_en.
- Contact lenses or other items intended to be introduced into or onto the eye.
- Products intended to be totally or partially introduced into the human body through surgically invasive means for the purpose of modifying the anatomy or fixation of body parts with the exception of tattooing products and piercings.
- Substances, combinations of substances, or items intended to be used for facial or other dermal or mucous membrane filling by subcutaneous, submucous or intradermal injection or other introduction, excluding those for tattooing.
- Equipment intended to be used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.
- High intensity electromagnetic radiation (e.g. infra-red, visible light and ultra-violet) emitting equipment intended for use on the human body, including coherent and non-coherent sources, monochromatic and broad spectrum, such as lasers and intense pulsed light equipment, for skin resurfacing, tattoo or hair removal or other skin treatment.
- Equipment intended for brain stimulation that apply electrical currents or magnetic or electromagnetic fields that penetrate the cranium to modify neuronal activity in the brain.
- Is the inclusion of a device on the Health Insurance Institute of Slovenia (ZZZS) reimbursement list within the competence of JAZMP?
The JAZMP does not have the power to include a device on the list of medical devices reimbursed by ZZZS. All economic operators established in the Republic of Slovenia and engaged in any activities related to medical devices are under a legal obligation to register in the relevant register maintained by JAZMP.
- Does JAZMP issue decisions in the English language?
No. JAZMP issues decisions in accordance with the legislation of the Republic of Slovenia and therefore in the Slovenian language. JAZMP is not competent for the translation into the English language.
- What requirements must medical devices that are subject to public procurement fulfil?
JAZMP has no competence to determine the procurement criteria. The criteria are determined by the contracting authority or the entity carrying out the public procurement procedure.
