1.1 Must distributors that were already registered under the previous legislation (MDD) register again?

Yes. In accordance with the Medical Devices Act (ZMedPri-1), a transitional period of three months is in force until 19 September 2025. Distributors that were already registered under the previous legislation (the Directives and the ZMedPri) are required to submit an application for registration by completing Form 857-02 (the official registration form of the Slovenian competent authority, JAZMP) and the mandatory annex, namely the table listing the medical device manufacturers conducting business with the distributor, as described on the JAZMP website under the Distributor registration section.

If a distributor is already registered as a distributor under the MDR/IVDR and entered in the register (after 26 May 2021 for medical devices or 26 May 2022 for IVD medical devices), it is required only to supplement the missing information, for example information on the person responsible for regulatory compliance. At present, submission via the SPOT portal is not possible; registration is carried out exclusively by means of the Form 869-02 available on the JAZMP website under the link Registration of economic operators. At the same time, the .xls table entitled “List of medical device manufacturers with whom the distributor conducts business” is required to be completed. The table includes the manufacturers and, where applicable, the authorised representatives, and constitutes a mandatory annex to Form 869-02. The table and the form are to be submitted to JAZMP at the following e-mail address: .

1.2 As an importer and distributor, do we need to complete separate forms?

Yes. If an entity performs the role of both importer and distributor, it is required to complete and submit separate forms for each role.

1.3 Is it necessary to include the manufacturer’s e-mail address in the table “List of medical device manufacturers” when registering?

Yes. The manufacturer’s e-mail address is mandatory at the time of registration.

1.4 Which manufacturers must the distributor indicate in the application form?

All manufacturers for whom the distributor makes devices available on the market of the Republic of Slovenia must be indicated. The manufacturer is always indicated on the device packaging and on all documents by which the manufacturer demonstrates the conformity of the device (the Declaration of Conformity and the notified body certificate).

1.5 What does it mean if an entity is already “registered under the new system”?

This means that, after the date of application of the MDR (from 26 May 2021) and the IVDR (from 26 May 2022), the entity has already been registered as a distributor or importer of medical devices. Even if the entity has already been entered in the register after the date of application of the Regulations, it is required to provide the information required under the Medical Devices Act (ZMedPri-1) by using the forms available on the JAZMP website and submitting them to the following e-mail address: .

1.6 Will JAZMP automatically transfer the data into the information system, or will distributors and importers be required to resubmit their data?

Until otherwise notified, entities are required to submit all data using the appropriate forms available on the JAZMP website. As the information system is due to be established within one year after the date of application of the ZMedPri-1, the data already submitted are expected to be transferred directly to the information system. Information on the procedure for reporting changes (such as newly established cooperation with manufacturers, changes of the person responsible for regulatory compliance, etc.) after the information system has been established will be provided once the procedures are in place. Until then, all changes are required to be reported using the appropriate forms available on the JAZMP website.

1.7 What does the importer’s obligation under Article 41 of the Medical Devices Act (ZMedPri-1) regarding the notification to JAZMP of each purchase mean?

The Act requires the importer to submit a declaration of conformity, the relevant certificates and communicate to the JAZMP any purchase that makes the device available on the Slovenian market when the device is first supplied. The technical manner of implementation (form/online application) has not yet been determined and will be clarified subsequently. JAZMP expects a response from the Ministry of Health in order to clarify the requirement concerned.

1.8 May the application (e.g. the registration form) be submitted a few days after the deadline?

Failure to submit on time means non-compliance with the law. We advise submitting the application on time or as soon as possible, and providing an explanation for the delay when submitting it.

1.9 Does JAZMP publish a list of distributors and the medical devices they place on the market?

The register of distributors in the Republic of Slovenia is published on the JAZMP website. The submitted “List of medical device manufacturers with whom the distributor conducts business” is information of a public nature; however, JAZMP will not make it publicly available. Within the EU, the principle of the free movement of goods applies, which means that medical devices that comply with EU legislation may be placed on the market freely among the Member States. In accordance with the legislation, records of the devices distributed are to be kept by the distributors themselves and made available to the competent authorities upon request.

1.10 In what manner can the authenticity of the declaration of conformity or the certificate for a medical device be verified?

• whether the document is complete (containing all mandatory information as laid down in Annex IV to the MDR and the IVDR),
• whether the certificate has been issued by a notified body designated for the certification of devices under one of the Directives, the MDR or the IVDR and entered in the NANDO database,
• whether the number of the notified body is consistent with the indication on the CE marking,
• whether the information on the certificate is consistent with the information on the device and its packaging.

In the event of doubts regarding the authenticity of the document or the origin of the device, consultation with JAZMP or verification of additional information directly with the manufacturer or the notified body is recommended.

In accordance with Article 13 of both Regulations, the importer is required, before placing the device on the market, to verify the declaration of conformity and all other information referred to in paragraph two of the same Article, in particular whether the manufacturer established outside the EU has appointed an authorised representative, who must also be indicated on the declarations and certificates.

In accordance with Article 14 of both Regulations, the distributor is required, before making the device available on the market, to verify the declaration of conformity and all other information referred to in paragraph two of the same Article. In doing so, the distributor may apply a sampling method, as described in more detail in the answers to questions 3.7, 3.8 and 3.9.

1.11 Is it sufficient for the importer to be indicated on the delivery note or a similar document accompanying the shipment? Is the addition of information by means of a label considered a manufacturer’s activity under Article 16 of the MDR?

No, the mere indication of the importer on the delivery note is not sufficient. The importer’s information is required to be clearly and permanently indicated on the medical device itself, on its packaging or in the accompanying documentation provided with the device to the final user. Such documentation is not limited to the delivery note but includes, for example, the instructions for use, the labelling on the packaging or another official accompanying document from which the importer’s information is clearly identifiable, in particular where contact between economic operators is required for reasons of the safety or performance of the device.

If the importer’s information is added by means of a label, this is possible only by agreement with the manufacturer. However, the procedure is required to be documented and traceable, and the added indication is required to be clear, permanent and accurate and not to obscure any information on the label provided by the manufacturer.

1.12 Does the UDI obligation also apply to “legacy devices”?

For so-called “legacy devices” (those lawfully placed on the market in accordance with the transitional provisions of the Regulations and compliant with the MDD or IVDD), the obligation to use the UDI system does not apply. Please also refer to the following MDCG Guidance documents: MDCG 2021-25 Rev. 1 (MDCG 2021-25 Rev.1) or MDCG 2022-8 (MDCG 2022-8).

1.13 Is the indication of the importer also required for “legacy devices”?

For “legacy devices”, the indication of the importer is not required, as set out in Article 13(3) of both the MDR and the IVDR. However, the importer, as an economic operator, must comply with the requirements of the MDR or IVDR even if it is not mentioned on the product. It is recommended to consult MDCG Guidance 2021-27.

1.14 How to proceed if there is insufficient space for the Slovenian labelling on the product?

If there is physically no space for additional information on the product, clear and permanent information is required to be provided in the accompanying documentation, which is unequivocally linked to the product (for example, by means of a label on the primary packaging or an enclosed document).

1.15 What should be done if we no longer intend to place the devices on the market and do not wish to register?

As long as the economic operator places the device on the market or makes the device available on the EU market, it is required to comply with the provisions of Article 13 or Article 14 of the Regulations, depending on the activity it performs, including the legal obligation to register in the information system, communication with the competent authority, device traceability, etc.

1.16 What falls within the definition of “distributor and importer”? For example, if the local representative office in Slovenia has no contracts with external providers for the sale of medical devices because the devices are sold on the basis of contracts concluded with the central company in the EU, is the local representative office required to register as a distributor/importer in such a case?

The definitions of the individual economic operators as laid down in the MDR and the IVDR are set out in Article 2.

Local representative offices of companies (so-called local agents or representatives) that, in a given Member State, perform certain tasks delegated by a manufacturer established in the EU or by a manufacturer that has an authorised representative established in the EU, and that do not carry out distribution or import activities in relation to medical devices, are not defined as economic operators under the relevant Regulations, nor are they specifically regulated therein. If the representative office performs only certain tasks of the manufacturer on its behalf, the legislation on medical devices in the Republic of Slovenia does not require the registration of such representative offices. If, in addition to carrying out the tasks of the manufacturer, the representative office also distributes and/or imports medical devices, it is required, in accordance with the relevant Regulations and the Medical Devices Act (ZMedPri-1), to register as an economic operator that places devices on the market or makes devices available on the EU market and to comply with the provisions of Article 13 or Article 14 of the Regulations.

1.17 Article 15 of the Medical Devices Act (ZMedPri-1) lays down the obligation to register distributors as economic operators in the distribution chain of medical devices. It is therefore relevant to determine whether this obligation also applies to local representative offices and marketing authorisation holders (MAHs) for certain medicinal products authorised in Slovenia. This concerns situations where the sale and distribution of medical devices are not carried out through the local representative office, but where contracts with external providers (local distributors/wholesalers) in Slovenia are concluded directly with the central company established within the EU. Should such a local representation be registered as an importer of medical devices? What about cases where the central company is established in a country outside the EU (for example the United Kingdom or Switzerland)? In such cases, is it necessary to register the local representative office as a distributor/importer?

Explained in question 1.16.

1.18 “Distributors are required to keep a register of complaints, non-conforming devices, recalls and withdrawals, to keep the manufacturer and, where available, the authorised representative and the importer informed of such monitoring, and to provide them with any information upon request.” – does this requirement cover all information, or must patient data be excluded due to data-protection obligations?

See also answer to question 8.1. The processing of personal data is required to comply with the applicable legal framework for data protection (the GDPR and the ZVOP-2). Personal data relating to patients for which the distributor has no legal basis are required to be appropriately redacted or anonymised before being provided. Information relating to the patient, where available, may be necessary, for example where a device has to be recalled from the market in order to protect the health of the individual patient.

2. OBLIGATIONS of manufacturers, authorised representatives and manufacturers of custom-made devices

2.1 Who determines the risk class of a device?

In accordance with the MDR and the IVDR, the manufacturer of a medical device is 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. This means that the manufacturer provides the device with all information necessary to ensure its safety and performance, as set out in Annex I to the MDR and the IVDR, assigns the device to the appropriate risk class in accordance with the classification rules in Annex VIII to the MDR and the IVDR, enters the conformity assessment procedure with a notified body in the case of higher-risk classes, etc.

2.2 Article 24: If a sample is marked as not intended for clinical use, must records nevertheless be kept of the type and quantity of samples distributed? (The purpose of such samples is to allow testing in a dental laboratory or by a dental technician in order to determine whether the material is suitable for use. These samples do not reach the final user – patient).

The provisions of Article 24 of the Medical Devices Act (ZMedPri-1) are required to be followed irrespective of whether the sample is used for clinical purposes or for testing in a dental laboratory. If any issues or irregularities are detected during the use of the sample that could affect the safety of use for either the healthcare professional or the patient or the performance of the device, they must be treated as a potential incident. In such cases the user or distributor must inform the manufacturer, who assesses the seriousness of the incident and where necessary notifies JAZMP. In the event of a serious incident or a suspected serious incident, the healthcare professional, operator or distributor is also required to notify JAZMP where this is required by legislation or where the manufacturer is not available or does not respond.

An economic operator that manufactures devices or makes devices available may provide samples to healthcare, pharmacy or other operators that use devices, provided that the following conditions are met:

• the device sample complies with all prescribed requirements applicable to devices,
• the device sample is marked with an indication that it is a sample,
• the device sample is provided in the smallest packaging unit,
• the economic operator distributing the samples keeps records of the type, quantity and recipients of the device samples, and
• the recipient is not permitted to sell the device samples.

2.3 If records of samples must be kept, is it sufficient for the samples to be included on invoices, or is a separate record required?

The Medical Devices Act (ZMedPri-1) stipulates the obligation to keep records but does not prescribe the specific manner in which this must be done. As explained above, the relevant records are always to be assessed from the perspective of incident handling. The records are to be clear and usable in situations requiring action.

2.4 Article 19: What is meant by the coverage of the financial consequences of the transfer and storage of documentation? Does the documentation refer to the technical documentation, the CE certificate and the declarations of conformity, or does it also include any other documents?

The manufacturer, the authorised representative or the sponsor having a registered office in the territory of the Republic of Slovenia is required, in the event of bankruptcy or cessation of its business activity, to ensure that the documentation referred to in Section 7 of Chapter III of Annex IX and Section 3 of Chapter III of Annex XV to Regulation (EU) 2017/745 (MDR), and in Section 6 of Chapter III of Annex IX and Section 3 of Chapter II of Annex XIV to Regulation (EU) 2017/746 (IVDR), is transferred to another economic operator that is not controlled by an affiliated person and is not in an ownership relationship with the economic operator that is bankrupt or has ceased its activity.

2.5 Is a liposuction device a medical device?

The manufacturer of the device is the economic operator that determines the intended medical purpose of the device. The MDR for the first time also regulates devices without an intended medical purpose, namely the products listed in Annex XVI to the MDR, in which paragraph four includes equipment used to reduce, remove or destroy adipose tissue, such as equipment for liposuction, lipolysis or lipoplasty.

2.6 Please provide an explanation of the wording in paragraph four of Article 19 and its meaning for the manufacturer. If, for objective reasons, the transfer of the documentation to another economic operator is not possible, the documentation is to be transferred to JAZMP, which is required to ensure its proper storage.

The transfer to JAZMP is defined as a measure of last resort, to be used only once all possibilities of transferring the documentation to another economic operator with which the original entity has an established agreement have been exhausted. And only after the transfer of the documentation to the trustee in bankruptcy is likewise not possible.

2.7 Paragraph one of Article 21 of the GDP – which one is meant?

GDP – Good distribution practice. It is recommended that the instructions set out in the guidance document for distributors, available on the JAZMP website, also be followed: guidance document.

2.8 Will JAZMP contact the manufacturer if a health institution reports an incident directly to JAZMP?

In accordance with the Regulations, when JAZMP receives a report from healthcare professionals, users or patients, it is required to establish direct communication with the manufacturer or its authorised representative in the EU. It is the responsibility of the manufacturer to immediately investigate the incident. Where additional information is required, JAZMP is also to contact the reporter, i.e. the healthcare professional or the health institution, for clarification. In the reporting form, the healthcare professional is to indicate whether they consent to their contact details being forwarded to the manufacturer. If they do not consent to the forwarding of their contact details, JAZMP will not provide this information to the manufacturer.

2.9 Who will carry out the supervision of the fulfilment of the requirements for a medical device manufacturer?

The inspection service of JAZMP carries out the supervision of economic operators operating in the Republic of Slovenia.

2.10 I would like to ask about the person responsible for regulatory compliance. Nothing was mentioned regarding the registration of this person with JAZMP. Is there a specific application form for this?

For this purpose, new forms have been made available on the JAZMP website under the section Registration of economic operators. The form, signed by the legal representative of the company, may be submitted to JAZMP by e-mail to the address .

2.11 What requirements does JAZMP impose on the authorised representative under Article 19 of the Medical Devices Act (ZMedPri-1) with respect to the retention of documentation?

The authorised representative must retain the documentation, including a copy of the technical documentation, the EU declaration of conformity and, where applicable, the certificate, and make it available to the competent authorities as required under paragraph eight of Article 10.

• Manufacturers are required to ensure that the technical documentation, the EU declaration of conformity and, where necessary, a copy of the relevant certificate, including any amendments and supplements issued in accordance with Article 56, are made available to the competent authorities for at least ten years after the last device to which the EU declaration of conformity relates has been placed on the market. In the case of implantable devices, this period is required to be at least 15 years after the last device has been placed on the market.
• Upon request by a competent authority, the manufacturer is required, as indicated therein, to provide that technical documentation in its entirety or a summary thereof.
• A manufacturer with a registered place of business outside the European Union is to ensure that its authorised representative has at all times access to the documentation necessary for the fulfilment of the tasks set out in paragraph three of Article 11.

The responsible person of the authorised representative is required to ensure that the economic operator has in place all agreements and procedures, including insurance covering the financial consequences of the transfer and retention of documentation, that guarantee that, upon cessation of activity for any reason, the documentation referred to in paragraph one of Article 19 will be transferred to another economic operator that is not controlled by a related party and is not owned by the economic operator that is insolvent or has ceased its activity.

2.12 Some entities are registered as manufacturers with the JAZMP although they are not recorded as such in the register of the Agency of the Republic of Slovenia for Public Legal Records and Related Services (AJPES). Which authority is responsible for monitoring this?

The Standard Classification of Activities (SKD) code is not one of the legally required data elements that a manufacturer of a device must provide to JAZMP when registering Most manufacturers of devices established in the Republic of Slovenia have this addressed due to clarification provided by JAZMP staff.

2.13 In which circumstances must JAZMP be notified within 8 days of the cessation of placing a medical device on the market?

Economic operators operating on the Slovenian market and engaged in activities involving medical devices are required under the Medical Devices Act (ZMedPri-1) to notify changes within eight days. This also includes a change concerning the cessation of placing the device on the market or making it available on the market.

2.14 What does the cessation of marketing a device mean? Does this mean that it is no longer available in the Republic of Slovenia or that the manufacturer has temporarily or permanently ceased its production?

The manufacturer of the device discontinues the production of the device, although any existing stock may still be placed on the market provided that the device is compliant and the certificate remains valid. Regulation (EU) 2024/1860 lays down requirements for reporting in the case of an anticipated discontinuation of production or any anticipated interruption of supply. In addition to the manufacturer, all other entities in the supply chain as well as the competent authorities of the EU Member States and the European Commission have a legal obligation to cooperate.

2.15 Regarding the register of samples, could you please explain its purpose so that we can ensure an appropriate register more effectively.

Article 24 of the Medical Devices Act (ZMedPri-1) stipulates the obligation to keep records but does not specify the manner in which this must be done. The registers in question should be assessed in terms of the actions to be taken in the event of an incident. The records are to be clear and usable in situations requiring action. If any issues or irregularities are detected during the use of the sample that could affect the safety of use for either the healthcare professional or the patient or the performance of the device, they must be treated as a potential incident. In such cases the user or distributor must inform the manufacturer, who assesses the seriousness of the incident and where necessary notifies JAZMP. In the event of a serious incident or a suspected serious incident, the healthcare professional, operator or distributor is also required to notify JAZMP where this is required by legislation or where the manufacturer is not available or does not respond.

2.16 Paragraph one of Article 21 of good distribution practice – could you provide the link or designation.

Guidance document for distributors is available at the following link: Guidance document. We also recommend reviewing the guidance on good distribution practice for medicinal products for human use, available at the following link: Good distribution practice.

2.17 As a manufacturer we registered before the adoption of the Act, after the MDR had entered into force, through EUDAMED and the SPOT portal. We have obtained a single registration number (SRN) Does the new Act require a renewed registration of the manufacturer. It is our understanding that the only new obligation in our case is the submission of evidence of competence for the person responsible for regulatory compliance (PRRC).

The requirements concerning the registration of manufacturers before EUDAMED becomes fully operational are set out in Article 42 of the Medical Devices Act (ZMedPri-1), while the requirements concerning the registration of the device, which is a legal obligation of the manufacturer, are set out in Article 45. In accordance with Article 42 of the Medical Devices Act (ZMedPri-1) evidence demonstrating the suitability of the person responsible for regulatory compliance must also be submitted to JAZMP, as required under Article 15 of the MDR and IVDR and Article 20 of the ZMedPri-1.

2.18 So this means that a new registration of the manufacturer is not required if the registration has already been carried out in accordance with the MDR, and only the evidence for the person responsible for regulatory compliance needs to be submitted.

There is no uniform answer. It should be verified whether, at the time of registration, all relevant documentation required under the Medical Devices Act (ZMedPri-1) was submitted and whether the requirements of Article 45 of ZMedPri-1, which governs the registration of devices and the notification of changes, were met.

The evidence demonstrating the suitability of the person responsible for regulatory compliance is certainly a new requirement introduced by the Act.

2.19 Is there a deadline by which the evidence of the suitability of the person responsible for regulatory compliance must be submitted.

The deadline for submitting the evidence for the person responsible for regulatory compliance is not specifically defined in the Medical Devices Act (ZMedPri-1). It is recommended that the entities referred to in paragraph one of Article 20 of the Medical Devices Act (ZMedPri-1) submit the supporting documents as soon as possible to the email address if they are already entered in the register of economic operators at the JAZMP. In the case of a first registration, submission of the supporting documents is mandatory at the time of registration.

2.20 Who can act as the person responsible for regulatory compliance at a manufacturer of medical devices and what profile is required?

The professional profile, understood as a precise description of the activities characteristic of a specific occupation and the physical and mental attributes required to perform them successfully, is not precisely defined for the person responsible for regulatory compliance at a manufacturer of medical devices.

The requirements are defined in Article 15 of the MDR or IVDR as follows:

• 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;
• 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.

3. OBLIGATIONS OF HEALTH INSTITUTIONS

3.1 Must health institutions that as part of their analyses determine that they are manufacturing in-house devices (for example IVDs) register as soon as possible (within three months from 19 June) or in accordance with the IVDR timelines which differ?

Paragraph one of the Medical Devices Act (ZMedPri-1) states:

A health institution that manufactures and uses devices in accordance with Article 5(5) of Regulation (EU) 2017/745 and Article 5(5) of Regulation (EU) 2017/746 must, before commencing the manufacturing and use of devices within the health institution, register in the information system.

Health institutions that manufacture in-house devices and are already registered in accordance with the Medical Devices Act (ZMedPri) must register within three months of the date on which the Medical Devices Act (ZMedPri-1) takes effect (Article 49 of the ZMedPri-1). At the same time they must notify JAZMP of the data referred to in paragraph two of Article 18 of the Medical Devices Act (ZMedPri-1).

 The timelines set out in the IVDR do not relate to registration but define the transitional periods for the requirements laid down in Article 5(5).

3.2 If health institutions are not yet registered does the 30-day deadline under Article 50 also apply to them as regards the person responsible for regulatory compliance?

The 30-day deadline from the entry into force of the Act governing the appointment of the person responsible for regulatory compliance and the person responsible for vigilance is laid down in paragraph three of Article 20 of the Medical Devices Act (ZMedPri-1), which requires health institutions to have within their organisation at least one person responsible for regulatory compliance and at least one person responsible for vigilance reporting.

Paragraph three of Article 20 applies to health institutions. Medical Devices Act (ZMedPri-1) defines health institutions as healthcare providers in accordance with the Act governing health services.

3.3 With regard to Article 18, which sets out the registration procedure and provides for the designation of the person responsible for vigilance (in accordance with Article 20), we would first like to know the following:

• How do the 30-day deadlines apply to the responsible person and to the registration of the institution?

A health institution is registered under the Medical Devices Act (ZMedPri-1) only if it is a reprocessor of single-use devices or if it manufactures and uses devices within the health institution.

If a health institution is already registered it must appoint the person responsible for regulatory compliance within 30 days from the date on which the Medical Devices Act (ZMedPri-1) enters into force. If it is registering for the first time, as required by the Act before commencing its activity, this must be done at the time of registration.

• How should the person responsible for vigilance be designated within a hierarchically complex institution, where professional activities are distributed across organisational subunits of the parent institution and further dispersed across different functional areas? Can more than one person responsible for vigilance be designated? If so, should such persons be linked to the individual organisational units carrying out the relevant activities, or is it preferable to designate a single person responsible for vigilance at institutional level?

The institution defines these decisions within its quality management system and justifies them on the basis of a risk assessment. Legislation regulating medical devices does not define these decisions.

3.4 19 July 2025 is the deadline for the registration of institutions, am I right? You replied that the responsible person for institutions that are not yet registered is designated at the time of registration. What is the deadline for health institutions to submit the application in the information system?

All health institutions appoint the person responsible for regulatory compliance and the person responsible for vigilance. In accordance with the Medical Devices Act (ZMedPri-1) only health institutions that manufacture and use in-house devices or reprocess single-use devices are required to register, and they must do so before commencing their activity. The person responsible for regulatory compliance and the person responsible for vigilance are notified to JAZMP only by health institutions that register because they carry out the above activities. Other health institutions appoint the respective persons and define their responsibilities and tasks within their quality management system.

3.5 When implementing Article 12(1) of the Medical Devices Act (ZMedPri-1), are health institutions expected to store the entire Unique Device Identification (UDI), consisting of the Device Identification (DI) and the Production Identifier (PI), or is it sufficient to store separate data elements such as the global trade item number (GTIN), production series, expiry date, and lot number, from which the full UDI can be reconstructed?

The UDI is assigned by the manufacturer in accordance with Annex VI to the MDR and the IVDR. The UDI also contains the UDI-PI, and traceability extends to the production batch.

In accordance with Article 27 of Regulation (EU) 2017/745 the unique device identification system (UDI system) also includes the storage of the UDI by economic operators, health institutions and healthcare professionals. Under Article 27(9) of the Regulation institutions must store and retain, preferably in electronic form, the UDI of devices that they have supplied or that have been supplied to them if these devices are class III implantable devices. Medical Devices Act (ZMedPri-1) adds the requirement that health institutions maintain a register in the same manner also for devices for which a notified body has issued a certificate and which they hold.

3.6 As the supervisory authority, could you clarify what the responsible persons of a health institution are required to do under paragraph three of Article 20 of the Medical Devices Act (ZMedPri-1) in the case of commercially available medical devices?

The person responsible for regulatory compliance must fulfil the obligations set out in Article 14(2) of the MDR and Article 14(2) of the IVDR and must maintain a register of the tasks performed.

With regard to the tasks of the person responsible for vigilance please refer to question 3.10.

3.7 The person responsible for regulatory compliance must fulfil the obligations set out in Article 14(2) of the MDR and Article 14(2) of the IVDR, as applicable to distributors of medical devices, and must maintain a register of the tasks performed. Which documents concerning medical devices must a health institution obtain and verify before putting them into service?

In accordance with Article 14 the person responsible for regulatory compliance verifies that the health institution puts into use only medical devices that comply with the Regulations. They verify that the device bears the CE marking, that the EU declaration of conformity has been drawn up, that the information referred to in Article 10(11) of Regulation (EU) 2017/745 or Article 10(10) of Regulation (EU) 2017/746 is provided, and that the manufacturer has assigned the UDI. For imported devices they verify whether the importer is indicated on the device, its packaging or the accompanying documentation.

3.8 Must these registered verifications relate to each delivery or only to each individual batch or lot of the medical device, given that a single batch or lot may be delivered several times?

Health institutions put into service only medical devices that comply with the Regulation. The standing operating procedures that form part of the quality management system describe the procedures by which the institution ensures the compliance of medical devices. Within its quality management system the institution also defines whether it applies sampling and, if so, what sampling method it uses in the procedures for verifying the compliance of medical devices. The decision to use sampling and the choice of method are typically based on expert judgement and a risk assessment. If sampling is not defined in the quality management system this means that the institution verifies compliance with the Regulations for each medical device before it is put into service.

3.9 If a sampling method may be used when verifying compliance with Article 14(a), (b) and (d) of the Regulation which sampling method do you recommend for the respective classes of medical devices?

JAZMP is not competent to provide recommendations on sampling methods for verifying the compliance of medical devices. The decision to use sampling and the choice of method are usually based on expert judgment and a risk assessment, which the individual institution incorporates and defines within its quality management system. We nevertheless emphasise the need for particular attention in the case of devices in higher risk classes. The manufacturer specifies the risk class in the declaration of conformity.

3.10 Regarding a “representative sampling method”, is there any definition of what quantities are considered representative in relation to the stock?

Please refer to questions 3.8 and 3.9.

3.11 What are the specific tasks of the person responsible for vigilance in a health institution?

The Act does not specifically define the tasks of the person responsible for vigilance. Based on its experience with the reporting of incidents by healthcare professionals, JAZMP provides the following information. A healthcare professional reports that an incident has occurred during the use of a medical device. Following the report, procedures are initiated to contact the distributor, manufacturer and service provider, to verify the supply chains, to assess the possibility of returning the device concerned, to package the device already used and to deliver it to the manufacturer for incident investigation. Based on previous practice, experts who use the device concerned often find it difficult, at later stages of determining the cause and resolving the issue, to cooperate either with us or with the manufacturer, distributor or service provider. For this reason it is foreseen that a person will be designated within the health institution who is either only familiar with the reporting process or reports on behalf of another person and handles the case until the cause is clarified and the resulting safety measure implemented, and who contacts or informs the healthcare professional if necessary. It is foreseen that this person maintains a list of reports submitted by healthcare professionals from the health institution concerned. JAZMP or the manufacturer or the distributor first communicates through this person in relation to the report concerned and, if necessary, subsequently with the healthcare professional directly. It is anticipated that this will result in a simplified and more efficient communication process.

The person responsible for vigilance is therefore the contact person of the health institution for matters related to vigilance. Medical Devices Act (ZMedPri-1) requires health institutions, for the purpose of an investigation related to a serious incident involving a device, to provide access to the device in respect of which a suspected serious incident has occurred and which has been reported. If this is not possible, the health institution shall provide a sample of an identical device. Economic operators that use devices in the course of their activities are required to maintain the devices in accordance with the instructions of the device manufacturer, which in this context also means monitoring notifications on corrective actions and following the additional instructions for use and maintenance of devices provided in the safety notices.

3.12 What are the tasks of the person responsible for reporting vigilance incidents involving purchased medical devices in a health institution, given that the Act does not define them? (Collection, reporting, training, registers, trend analysis, CAPA, etc.?)

With regard to the tasks of the person responsible for vigilance please refer to question 10 and its answer.

3.13 How should a hospital pharmacy proceed? Must it have its own person responsible for vigilance and its own person responsible for regulatory compliance, or can these functions be organised at hospital level?

A hospital pharmacy as a unit of the economic operator is organised by the healthcare provider at the secondary or tertiary level of healthcare services. The medical institution defines these decisions within its quality management system and justifies them on the basis of a risk assessment. Legislation regulating medical devices does not define these decisions.

3.14 Must vigilance be included in the umbrella quality management system of the health institution, or only in the quality management system of the service or department that carries out the receipt, storage and distribution of medical devices within the health institution?

Depending on their quality management systems, hospitals have procedures in place that ensure the safety and quality of medical care. This framework typically includes risk management within the health institution, as well as the monitoring of incidents and complaints concerning medical devices, thereby ensuring patient safety.

When handling complaints and communicating with the distributor, it is important that the health institution assesses whether any of the reported events may also be classified as an incident, and that it acts on this information in accordance with the legislation.

3.15 How does this take into account the requirement of paragraph one of Article 30 of the Medical Devices Act (ZMedPri-1), which provides for direct reporting by healthcare professionals to JAZMP?

The obligation under the Medical Devices Act (ZMedPri-1) to report serious incidents lies unequivocally with each individual healthcare professional, and the Medical Devices Act (ZMedPri-1) does not define the relationship between the healthcare professional and the person responsible for vigilance. The legal organisational forms and the sizes of institutions vary, and the relationships between healthcare professionals and the person responsible for vigilance are defined differently within the quality management system.

3.16 How should pharmacies operating outside health institutions be treated? Are they considered health institutions, given that under the Medical Devices Act (ZMedPri-1) they are defined as distributors? How should the appointment of the person responsible for regulatory compliance and the person responsible for vigilance be handled? Is it the same as for distributors?

Community pharmacies are healthcare providers in accordance with the Act governing healthcare services and, at the same time, distributors under the MDR, the IVDR and the Medical Devices Act (ZMedPri-1). The requirements of the Regulations, the Medical Devices Act (ZMedPri-1) and the Health Services Act apply to them.

3.17 Who may act as the person responsible for regulatory compliance and the person responsible for vigilance in a pharmacy? May this be an external person, given that a confirmation by the economic operator is required demonstrating at least one year of work experience with a quality management system for medical devices?

Article 20 of the Medical Devices Act (ZMedPri-1) provides that health institutions and distributors must have within their organisation at least one person responsible for regulatory compliance and at least one person responsible for vigilance reporting. These persons 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. The tasks of the person responsible for regulatory compliance may also be performed by the person responsible for vigilance reporting.

Under the Medical Devices Act (ZMedPri-1), the person responsible for vigilance must be part of the organisation of the undertaking. The Medical Devices Act (ZMedPri-1) permits the person responsible for regulatory compliance to be outside the organisation only for distributors and importers classified as micro or small undertakings. In such cases, the economic operator is to verify that the person meets the required conditions or qualifications and that this person is available to them on a continuous and uninterrupted basis.

3.18 Steam sterilisation procedures. Under the Medical Devices Act (ZMedPri-1), is the sterilisation procedure for medical devices treated as a manufacturing process, and must a health institution that carries out sterilisation for its own needs within its activities register under Article 18 of the Medical Devices Act (ZMedPri-1) (example 1: sterilisation of reusable devices; example 2: sterilisation of non-sterile swabs performed in accordance with the manufacturer’s instructions)?

Article 18 of the Medical Devices Act (ZMedPri-1) defines the registration of health institutions that manufacture and use devices within their organisation. Article 17 of the Medical Devices Act (ZMedPri-1) defines the registration of health institutions that carry out the reprocessing of single-use devices. Non-sterile swabs and devices intended for re-use are not defined as devices that a health institution manufactures and uses, nor as single-use medical devices that a health institution reprocesses.

If a device is intended by the manufacturer for re-use, it is important that the sterilisation is performed in accordance with the manufacturer’s instructions and that the procedure carried out is repeatable and verifiable, or appropriately defined and documented within the quality management system of the health institution. The same applies if the manufacturer places a non-sterile device on the market and provides for and prescribes the sterilisation of the device in the instructions for use.

3.19 When can we expect guidance on the use of reagents, the requirements for reagents and the more complex in-house tests used in specialised clinical laboratories?

JAZMP is not competent to provide guidance on the use of reagents and the requirements for them. Such instructions and requests are usually adopted by professional associations and organisations with a sufficient number of specialised experts in each field. Health institutions are advised to define a quality management system that incorporates the relevant expert requirements into standard operating procedures and verifies and evaluates them in accordance with the legislation on medical devices.

3.20 How should reporting be handled in the case of an in-house device? In such cases, is the product not returned to the manufacturer or supplier? Do we report to JAZMP? Anywhere else?

In-house devices are devices (MD and IVD) that are manufactured and used within a health institution in accordance with Article 5(5) of the MDR or the IVDR, when the specific needs of the target patient group cannot be met adequately by an equivalent device available on the market. In the case of in-house devices, the health institution itself assumes the role and the responsibilities of the manufacturer. In the event of incidents, the devices are therefore not returned to the manufacturer. The health institution examines the experience gained from the clinical use of these devices and takes all necessary corrective actions, as further explained in the MDCG 2023-1 guidance, link MDCG 2023-1. As a manufacturer, the health institution must document within its quality management system the procedure for collecting clinical data and performance data, the handling of incidents and corrective actions, while the reporting to the competent authorities is determined by national legislation. Medical Devices Act (ZMedPri-1) requires the reporting to JAZMP of any suspected serious incident involving a device under Article 87(1)(a) of Regulation (EU) 2017/745 and Article 82(1)(a) of Regulation (EU) 2017/746. JAZMP may, for the purpose of verifying compliance, request the full documentation on in-house devices from health institutions.

4. PERSON RESPONSIBLE FOR REGULATORY COMPLIANCE AND VIGILANCE

4.1 May the name of the person responsible for regulatory compliance or vigilance be submitted after the statutory deadline of 19 July 2025 if the entity is unable to complete the appointment by that date?

The deadline of 19 July 2025 is stipulated by law and requires the appointment of the person responsible for regulatory compliance and the person responsible for vigilance by that date. Any delay must be assessed on an individual basis, although JAZMP recommends that the obligation be fulfilled on time.

4.2 Can a Master of Pharmacy with one year of experience in a pharmacy be appointed as the person responsible for regulatory compliance?

Medical Devices Act (ZMedPri-1) stipulates in paragraph three of Article 20 that health institutions and distributors, except those that make available only the devices referred to in paragraph four of Article 21, must have within their organisation at least one person responsible for regulatory compliance.

This person must have appropriate expert knowledge of medical devices, which is demonstrated by a confirmation issued by the economic operator showing at least one year of work experience with legislative requirements or a quality management system related to medical devices. The suitability may also be demonstrated by a copy of the contract or another relevant document.

In addition, this person must ensure the fulfilment of the obligations under Article 14(2) of the MDR and the IVDR and keep a record of the tasks performed, which serves as evidence of the fulfilment of their obligations.

A Master of Pharmacy may meet the requirement regarding appropriate education; however, one year of general experience in a pharmacy is usually not sufficient if it does not include specific work involving legislation, quality or the oversight of medical devices. The employer must assess whether the person has appropriate expert knowledge in accordance with the statutory criteria.

4.3 Does the person responsible for vigilance need to have a specific level of education in distributors and health institutions?

Paragraph three of Article 20 of the Medical Devices Act (ZMedPri-1) provides that health institutions and distributors, except those that make available only the devices referred to in paragraph four of Article 21, must have within their organisation a person responsible for vigilance reporting.

The Act does not specify a particular level of education for this person, but the person must have appropriate professional expertise relating to the medical devices handled by the economic operator.

The appointed person must also be competent to recognise incidents, notify manufacturers or competent authorities, keep records of incidents and participate in vigilance procedures, as set out in the provisions of the MDR (Articles 87–92) and the IVDR (Articles 82–87), adapted to the role of distributors and users of devices. Their tasks include providing support within the vigilance system of the manufacturer and the competent authorities.

4.4 What requirements apply to the person responsible for regulatory compliance and the person responsible for vigilance reporting at an importer of medical devices?

• a diploma, certificate or other evidence of education obtained under a second-cycle study programme, or education equivalent to a second-cycle qualification and classified at level 8 under the Act governing the Slovenian Qualifications Framework, in the field of law, medicine, pharmacy, engineering or another scientific discipline, or
• a confirmation issued by the economic operator in the field of medical devices demonstrating at least one year of work experience with legislative requirements or a quality management system related to medical devices, or a copy of the contract or another relevant document.

4.5 Can the roles of the person responsible for regulatory compliance and the person responsible for vigilance be performed by the same person?

Yes. Provided the person has appropriate knowledge and experience in both areas and is not in a conflict of interest, they may perform both functions.

4.6 Can more than one person responsible for regulatory compliance be appointed in accordance with the internal allocation of responsibilities?

The decision on the internal organisation and the division of tasks lies within the competence of the management of the undertaking. In practice, it is possible for an economic operator to establish a system in which, due to the scope of its activities or the complexity of its operations, the tasks related to regulatory compliance or vigilance are internally divided among several persons. However, for the purposes of external reporting and oversight, one person responsible for regulatory compliance and one person responsible for vigilance reporting must always be officially appointed. The names and contact details of these persons must be notified to JAZMP, as required by the legislation.

Support roles or substitute persons may be organised within the economic operator as needed, provided that the relationships, responsibilities and communication flows are clearly defined and documented. It is essential that the officially appointed persons are able to ensure comprehensive oversight of the fulfilment of the statutory obligations.

4.7 Is it obligatory to register each person individually if the tasks are divided internally?

No. Only one person responsible for regulatory compliance and one person responsible for vigilance are to be officially registered. Internal organisational arrangements may involve several persons, but this is not registered with JAZMP unless there is an official change of the responsible person.

4.8 Is it acceptable for the person responsible for regulatory compliance and or vigilance to be an external contractor from another EU Member State?

Yes. An external personnel may come from any EU Member State if they meet all competence requirements and are accessible for the effective performance of their tasks.

4.9 Is the registration of the person responsible for regulatory compliance or vigilance obligatory even if the person was appointed before the Medical Devices Act (ZMedPri-1) came into force?

Yes. The information on the contact persons is part of the registration of the distributor or importer and is a new requirement under the Medical Devices Act (ZMedPri-1).   

4.10 Must an economic operator from another EU Member State also appoint a person responsible for compliance or vigilance?

No. The legislation in the Republic of Slovenia provides only for the registration of economic operators with their place of establishment in the Republic of Slovenia, for which the obligation to submit the data applies.

5. INSTRUCTIONS FOR USE, LABELLING AND PACKAGING

5.1 Is it mandatory for the instructions for use to be provided in the Slovenian language?

Yes. In accordance with paragraphs five and six of Article of the Medical Devices Act (ZMedPri-1), the instructions for use must be provided in the Slovenian language if the medical device is intended for lay persons.

If the device is intended exclusively for professional use within a health institution, the instructions for use may also be provided in another language that is understood by the professional users. In this case, the responsibility lies with the economic operator that supplies the medical device to the health institution to ensure that the instructions for use are provided in a language and format that allow the safe and correct use of the device. 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.

5.2 May the original labelling of the manufacturer be overlaid with the Slovenian translation?

Ne. Overlaying of the original labelling with a translation is not permitted. The Slovenian translation must be added without obscuring the original labelling. This applies in particular to the manufacturer’s details, the serial number and other key markings.

5.3 How is the sale of medical devices regulated? For example, is it possible for an external pharmacy to sell a medical device, such as syringes, to lay end users individually when the individual units do not contain all the information on the packaging and only one set of instructions for use is supplied in the full box (50 units), and how can this be carried out in practice?

If the manufacturer has envisaged sale in this manner and each device is supplied with its own instructions for use, it may be placed on the market in this way. Otherwise, the repackaging falls under Article 16(2) of the MDR or the IVDR, which sets out the circumstances in which the distributor or importer assumes the obligations of the manufacturer. See also the following questions 5.4 and 5.5.

5.4 May a pharmacy sell individual units of medical devices if the manufacturer has provided only one set of instructions for use for the entire package?

If a medical device is packaged in such a way that the instructions for use are provided only once for the entire package (for example one set of instructions for 100 units), this indicates that the manufacturer has not envisaged the sale of individual units. The sale of individual units in this case constitutes repackaging, which represents a regulatory intervention in the original condition of the device. A medical device may be sold as individual units only if each unit is already in its original inner packaging and contains clear labelling identical to the outer packaging together with the instructions for use for that unit.

If these conditions are not met, the sale of individual units without appropriate instructions for use is not permitted.

5.5 Who is responsible for providing instructions for use when selling individual units? May the pharmacy prepare the translation itself?

No. The manufacturer is solely responsible for the content and provision of the instructions for use. A pharmacy must not itself prepare, translate or supplement the instructions for use; it is required to follow the requirements set out in Article 16 of the MDR and IVDR.

• prepared by the manufacturer;
• an economic operator that has carried this out under an established quality management system (QMS) and obtained a certificate from a notified body (Article 16(4) of the MDR and IVDR).

5.6 Are instructions for use permitted exclusively in electronic form (e-IFU)?

Instructions for use provided exclusively in electronic form were permitted under Commission Implementing Regulation (EU) 2021/2226, although their use was initially limited to specific devices, such as fixed installed medical devices or devices intended exclusively for use by professionals. With the adoption of Commission Implementing Regulation (EU) 2025/1234 of 16 July 2025, this option is extended to all medical devices and their accessories intended for professional users. This means that, from that date, the manufacturer may provide the instructions exclusively in electronic form, provided that the conditions are met, including reliable and secure accessibility, on-screen readability and the possibility of accessing previous versions.

For devices intended for the general public, electronic instructions remain permissible only as an additional option, while the primary requirement continues to be the printed form.

5.7 May a health institution request instructions for use in the Slovenian language after delivery, even if it agreed to instructions in English prior to delivery?

Paragraph six of Article 7 of the Medical Devices Act (ZMedPri-1) specifies that instructions for use intended for professional users may be provided in a language they understand. If the institution requests instructions for use in the Slovenian language, the economic operator is required to provide them immediately or within 10 days at the latest. Please also refer to question 5.8 together with its answer.

5.8 May a health institution that has already agreed to the use of instructions in a foreign language subsequently request a Slovenian translation? And does the 10-day period for providing the translation also apply to contracts already concluded or to goods already delivered?

In accordance with Article 7 of the Medical Devices Act (ZMedPri-1), a medical device must be accompanied by instructions in the Slovenian language, unless it is intended for a professional user who explicitly agrees to the use of instructions in another language. If the health institution has formally agreed to the use of instructions in a foreign language upon receipt of the goods, it has already indicated the language that is acceptable for its use.

The 10-day period for providing the translation of the instructions applies from the moment the health institution formally requests the translation from the distributor or importer. In the case of an already concluded contract and ongoing supply, such a request requires verification of the contractual obligations and any potential implications for the implementation of the contract.

6. PERSON RESPONSIBLE FOR TECHNICAL ADVICE

6.1 What does it mean to have a person responsible for technical advice available (is a call-centre agent sufficient)?

Medical Devices Act (ZMedPri-1) requires that an economic operator placing medical devices on the market is to have, throughout its operating hours, a person responsible for technical advice available who can immediately provide the purchaser or user with reliable information on the safe and correct use of the device.

6.2 Regarding sales to professional users and lay persons – is the term “professional user” defined anywhere? For example, is a retired registered nurse considered a professional user or not?

The definition of a “lay person” derives from Article 2 of the Regulations, as follows:

“lay person” means an individual who does not have formal education in a relevant field of healthcare or medical discipline.

A nurse cannot automatically be regarded as a professional user, as she may lack the specific knowledge required for the medical devices she handles. The range of medical devices is very broad. There are over 500,000 different devices on the EU market. It is also among the most rapidly developing areas. In recent years, the market has seen a growing number of software-based devices, nanotechnology solutions, 3D-printed products and similar innovations.

7. REPORTING OF INCIDENTS AND FIELD SAFETY CORRECTIVE ACTIONS (FSCA)

7.1 How should a healthcare professional decide whether an event related to a medical device must be reported?

A healthcare professional must report any suspected serious incident involving a medical device, even if the incident appears minor or resulted in no harm to the patient or user, provided that a recurrence of such an incident could lead to serious harm.

It is not the task of a healthcare professional to determine or confirm whether an event constitutes a serious incident. It is crucial that any suspected serious incident is recorded and reported to both the competent authority and the distributor or manufacturer. The manufacturer or its authorised representative is required, within its quality management system, to assess and justify whether an event constitutes a serious incident requiring regulatory reporting or an incident or expected undesirable side effect that must be recorded and monitored as part of trend analysis.

Accordingly, the JAZMP recommends that healthcare professionals report whenever there is uncertainty as to whether an event is an incident or a serious incident, given that reporting is essential for ensuring device safety and for effective post-market surveillance.

7.2 Is the distributor required to forward all complaints and reports to the manufacturer?

Yes. Under Article 14(5) of the MDR and Article 14(5) of the IVDR, the distributor is to immediately forward to the manufacturer any complaints, information on suspected incidents or any suspicions of non-compliance received from healthcare professionals, patients or users. If there is a suspicion that a medical device presents a serious risk to public health or safety, or if the device is suspected to be falsified, the distributor is also to notify the JAZMP directly, as required under Article 14(2) of the MDR and IVDR.

7.3 As a pharmacy professional, should I report serious incidents involving medical devices using Form 528-xx or Form 685-x?

As pharmacy professional is classified as a healthcare professional and is required to report any suspected serious incident involving a medical device using Form 528-xx.

Under the Medical Devices Act (ZMedPri-1) and under the MDR (Regulation (EU) 2017/745) and IVDR (Regulation (EU) 2017/746), a pharmacy is also classified as a distributor of medical devices. Consequently, any information on complaints or suspected incidents must be forwarded to the manufacturer without delay and, where applicable, to the manufacturer’s authorised representative.

Where there is a suspicion that a medical device placed on the market presents a serious risk or is a falsified medical device, JAZMP must be notified using Form 685-xx (Article 14(2) of the MDR).

7.4 How should a serious incident be managed when it occurs in relation to a medicinal product prepared by the pharmacy, but the suspected source of the incident is a medical device (e.g. a subcutaneous pump)?

In such cases it is essential to pay particular attention to the distinction between the medicinal product and the medical device. If a medical device is suspected to have been involved in the incident, it is essential to report this through the medical device vigilance system as well.

The report may be submitted either to the pharmacovigilance system (if the case concerns a medicinal product) and/or to the medical device vigilance system.

Pharmacovigilance and medical device vigilance within the JAZMP cooperate closely. It is therefore advisable to submit reports to both systems whenever there is any doubt regarding the cause of the incident. This is to ensure that all information is properly processed and shared with the competent risk assessment experts.

Include as much information as possible about the device (e.g. the device involved in the incident, serial number, LOT, photograph, sample), as this significantly contributes to the effective handling of the case and to ensuring patient safety.

7.5 Is the distributor required to notify the competent authority of another EU Member State, where the medical device has been made available by the distributor, that a field safety corrective action has been implemented for that device?

• inform the manufacturer about distribution to other countries;
• ensure that end users or subsequent distributors in those countries are appropriately informed about the implemented field safety corrective action;
• immediately notify the JAZMP in the event of a serious risk and, if agreed with the manufacturer, assist in informing other competent authorities;
• cooperate with the manufacturer and, where necessary, with the manufacturer’s authorised representative, the importer and the competent authorities to ensure that the necessary corrective actions are taken.

As a rule, notifying foreign competent authorities is the responsibility of the manufacturer. However, the distributor must ensure that the manufacturer has all necessary information on the geographical scope of distribution of the device.

7.6 Who reports the completion of a field safety corrective action (FSCA) – the manufacturer or the distributor?

The completion of a field safety corrective action (FSCA) is formally reported and finalised by the manufacturer, as the manufacturer is responsible for the full implementation of the action, including the preparation and submission of both the initial and the final report to the competent authority.

The distributor has a key supporting role in this process. The distributor is required to cooperate in the implementation of the action at the market level, which includes the timely and effective communication of information to its customers, including subsequent distributors and end users, and the execution of all necessary measures specified by the manufacturer. Furthermore, the distributor must provide the manufacturer with information on the actual implementation of the action (e.g. the number of users reached, the number of products replaced), so that the manufacturer can prepare a complete implementation report for the competent authority.

Although the distributor is not responsible for the formal reporting of the completion of an FSCA, its active role is essential for the effectiveness and traceability of the action.

7.7 Who may translate a field safety notice (FSN – Field Safety Notice)?

The translation of a field safety notice (FSN), which forms part of a field safety corrective action (FSCA), is the responsibility of the manufacturer. The manufacturer must ensure that the translation is accurate, consistent with the original and identical in all Member States in which the action is implemented. Although the translation may be carried out by an authorised representative or a translation service, the responsibility for the adequacy of the translation remains with the manufacturer. The distributor may not alter the content or format of the document, including its header, but may verify the consistency of the translation with the original and notify the manufacturer of any discrepancies. Such cooperation contributes to clear, accurate and timely communication with medical device users.

7.8 What is a malfunction, and must it be reported?

A malfunction of a medical device means any failure, deficiency or irregularity in its performance that may occur during use or during checks carried out before use, even when the device has been used in accordance with the manufacturer’s instructions.

If a malfunction has, or could have, an impact on the safety of the patient, the user or another person, or on the performance of the device, it must be treated as a potential incident. In such cases the user or distributor must inform the manufacturer, who assesses the seriousness of the incident and where necessary notifies JAZMP.

In the event of a serious incident or a suspected serious incident, the healthcare professional, operator or distributor can also have a duty to notify JAZMP where this is required by legislation or where the manufacturer is not available or does not respond.

It is important that the device is used in accordance with the manufacturer’s instructions, as this forms the basis for determining whether an issue constitutes a device malfunction or a use error.

8. STRACEABILITY, RECORD-KEEPING AND REPACKAGING

8.1 Which classes of medical devices require traceability to the end user?

Article 25 of the MDR and Article 22 of the IVDR stipulate that economic operators involved in the supply chain of medical devices ensure traceability of the devices in such a way that they can always identify from which economic operator they have received a device and to which operator they have supplied it. General traceability to the end user is not mandatory for all devices, but is explicitly required for implants, for which specific rules apply, including the obligation to provide the patient with an implant card (Article 18 of the MDR).

For other devices, traceability to the end user may represent good practice or an internal requirement of the quality management system, but it is not established as a legal obligation. However, all economic operators must provide distribution data at the request of the competent authorities where this is necessary for ensuring safety or for the purposes of vigilance.

8.2 How long must the importer retain UDI data?

In accordance with Article 41 of the Medical Devices Act (ZMedPri-1) and Article 10 of the MDR and IVDR, the importer must retain the data related to the Unique Device Identification (UDI) for at least 10 years after the last device has been placed on the market, irrespective of the device’s risk class. For implantable devices under the MDR, this period is 15 years after the last device has been placed on the market.

8.3 How should the contents of a larger package be handled when they need to be divided into smaller units?

If the contents of a larger package of medical devices are divided into smaller units (e.g. from a package containing 100 sterile items), this will generally constitute an activity that goes beyond distribution. In such cases the requirements of Article 16 of the MDR and IVDR must be followed.

This is permitted only where the individual items are already in their original inner packaging with their own markings and instructions for use as provided by the manufacturer. Otherwise, breaking the package down into smaller units is not permitted without meeting additional regulatory requirements.

8.4 Is it permitted to repackage wound dressings without instructions for use?

If the product is a class I or class IIa medical device for which instructions for use are not required because it can be used safely without them, and if the repackaging does not affect the sterility or any other essential characteristics of the device, such repackaging may be permitted without the obligation to have a certified quality management system. The possibility of omitting instructions for use in such cases is defined in Annex I, point 23.1(d) of the MDR.

The distributor must ensure that all mandatory information provided by the manufacturer is preserved, including the UDI marking and the information in the Slovenian language. If these conditions are not met, or if the repackaging affects the safety or functionality of the device, the distributor is considered to assume the role of the manufacturer in accordance with Article 16 of the MDR and IVDR, which entails additional regulatory obligations, including an appropriate quality management system.

8.5 How to proceed if the manufacturer’s packaging does not allow the addition of the label in the Slovenian language?

If the packaging of the medical device does not allow the physical addition of the label in the Slovenian language, the distributor must ensure that the required information is clearly and permanently available in Slovenian on a separate accompanying document that unambiguously belongs to the device.

9. ADVERTISING AND SAMPLES

9.1 How is the advertising of medical devices regulated? Will a specific regulation be issued for this matter?

The advertising of medical devices must comply with Article 7 of the MDR, which stipulates that information, including advertising, must not be misleading with regard to the intended purpose, safety, performance or clinical benefits of the device.

The Medical Devices Act (ZMedPri-1) further stipulates in Article 23 that the advertising of medical devices must be truthful, clear, verifiable and consistent with the labelling and instructions for use, and must not be misleading. Advertising that is contrary to the Regulations or to the Medical Devices Act (ZMedPri-1) is prohibited.

A specific implementing regulation for the advertising of medical devices under the Medical Devices Act (ZMedPri-1) is currently not envisaged.

9.2 Is the distribution of medical device samples at conferences permitted?

Yes, provided that the conditions defined in Article 24 of the Medical Devices Act (ZMedPri-1) are met.

• the sample complies with all applicable requirements for medical devices;
• the sample is clearly marked as a sample;
• the sample is in the smallest unit of packaging;
• the economic operator keeps a record of the type and quantity of samples distributed.

• in addition to the type and quantity, the record must also contain information on the recipient; and
• the recipient of the sample may not sell it.

9.3 Does the requirement to use the smallest unit of packaging also apply to samples requested in public procurement procedures?

Yes. The requirement to use the smallest unit of packaging is one of the conditions defined in Article 24 of the Medical Devices Act (ZMedPri-1) and applies irrespective of the context in which the samples are distributed, including cases where samples are requested within public procurement procedures.

9.4 Is any specific method foreseen for keeping records of medical device samples?

The Medical Devices Act (ZMedPri-1) stipulates the obligation to keep records but does not prescribe the specific manner in which this must be done.

• when distributing to the general public: keep records of the type and quantity of samples;
• when distributing to providers of medical, pharmacy or other activities: keep records of the type, quantity and recipients.

10. LEGACY DEVICE

10.1 Do declarations of conformity under the MDD/IVDD remain valid until the new MDR/IVDR deadlines for obtaining CE certificates?

The manufacturer demonstrates the validity of the certificate only where the conditions of Regulation (EU) 2023/607 are fulfilled. The regulation also defines the new validity periods of certificates according to the risk class of the device.

10.2 When dealing with a legacy device for which a confirmation letter from the notified body and the manufacturer’s declaration of conformity for re-certification are available, why do pharmacies still request the additional old MDD declaration of conformity referring to the expired EC certificate and the corresponding certificate, even though the transitional declarations already include references to the certificates with extended validity and the related declarations of conformity?

“Legacy device” refers to a device compliant with one of the Directives which, in accordance with the transitional provisions laid down in Regulation (EU) 2023/607 for medical devices and Regulation (EU) 2024/1860 for in vitro diagnostic medical devices, may lawfully be placed on the market until the expiry of the applicable transitional period.

Practice in the Republic of Slovenia shows that manufacturers, in order to facilitate placing the devices on the market, have updated their declarations of conformity by indicating the new validity period of the certificate. Consequently, this means that a manufacturer established in the Republic of Slovenia must update the registration of the devices in the medical device register maintained by the JAZMP in accordance with the legislation. When the application is submitted, the JAZMP verifies all the information provided, the alignment of product names and the actual agreement concluded with the notified body on entering the certification procedure. A “corrected” declaration alone is not sufficient evidence.

11. IMPLANT CARD

11.1 Do screws and plates require an implant card?

No. In accordance with Article 18(3) of the MDR, certain implants such as screws, plates, pins and wires are exempt from the obligation to provide an implant card.

12. FEES

12.1 How will the fees for distributors and importers be determined?

The amount and the method of payment of the fees are defined in the tariff adopted by the JAZMP Council under Article 32 of the Medical Devices Act (ZMedPri-1). It will be established in a transparent manner and on the basis of the cost-recovery principle as defined in Article 111 of the MDR and Article 104 of the IVDR.

Until the new tariff is adopted, the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia [Uradni list RS], No 24/19) apply.

12.2 How is separate accounting for medical devices ensured, and which supporting documentation is appropriate?

Separate accounting means that the obliged entity keeps accounting records that clearly demonstrate the separation of revenue from activities involving medical devices from other revenue. The appropriate supporting documentation will be defined in the tariff, which must be adopted within six months of the adoption of the Act. If separate accounting is not ensured, the annual fee is determined on the basis of the obliged entity’s total net revenue (Article 32 of the Medical Devices Act (ZMedPri-1)).

12.3 Who will be the payer of the tariff if a legal person merely promotes sales while the medical device is placed on the Slovenian market by another entity?

In accordance with Article 32 of the Medical Devices Act (ZMedPri-1), the payer of the fee is the petitioner of the proceedings or the entity carrying out the activity on the Slovenian market.

The determination of the actual payer among several participating entities (e.g. the manufacturer, the distributor or the promoter) is a matter of mutual contractual agreement.

12.4 What does the provision in Article 32 of the Medical Devices Act (ZMedPri-1) concerning the separation of revenue mean?

If the obliged entity keeps separate financial records, the basis for the annual fee is the revenue generated from activities involving medical devices. The appropriate supporting documentation will have to be submitted to the JAZMP within the deadline defined in the tariff, which must be adopted within six months of the adoption of the Act. If the obliged entity does not keep separate financial records, the basis is the entity’s total net annual revenue.

12.5 How are the tariff rates for registration or the annual charges determined?

The rate will be determined in the new tariff, which must be adopted by the JAZMP Council no later than six months after the Medical Devices Act (ZMedPri-1) enters into force. The tariff rate will be established in a transparent manner, in accordance with the cost-recovery principle as set out in Article 111 of the MDR and Article 104 of the IVDR.

Until the new tariff is adopted, the Rules on fees in the field of medical devices (Official Gazette of the Republic of Slovenia [Uradni list RS], No 24/19) apply.

13. OTHER

13.1 Why did you state that the natural or legal person referred to in Article 22 of the MDR is a manufacturer? This person does not place devices on the market or put them into service and therefore does not meet the definition of a manufacturer under Article 2 of the MDR.

On the basis of paragraph one of Article 20 of the Medical Devices Act (ZMedPri-1) and Article 22 of the MDR, a natural or legal person is not considered a manufacturer according to the definition in Article 2 of the MDR in this context, but is subject to specific obligations defined in that Article. Such a person is one of the economic operators that will have to be registered in the EUDAMED medical device database.

This is a specific case in which the person is not formally a manufacturer according to the definition, but due to their role in combining or adapting devices, assumes certain regulatory obligations.

13.2 When will the JAZMP prepare and publish the list referred to in the third indent of paragraph four of Article 21 of the Medical Devices Act (ZMedPri-1)?

The list defined in the third indent of paragraph four of Article 21 of the Medical Devices Act (ZMedPri-1) will be published once the preparation procedures have been completed. Relevant information and documents will be made available through publications on the JAZMP website.

13.3 Are custom-made prescription corrective glasses considered adaptable medical devices?

It is necessary to follow the MDCG 2021-3 guidance document – Questions and Answers on Custom-Made Devices, available at the following link: MDCG 2021-3. However, each case must be assessed individually.

13.4 How should small and medium-sized enterprises ensure additional resources for meeting all additional obligations, adapting their information systems and implementing both the new e-system and EUDAMED, given the uncertainties regarding the required qualifications and the demonstration of the competencies of responsible persons, as well as the need to comply with Regulation (EU) 2023/988 on general product safety?

An exemption for small and medium-sized companies is provided in Article 15 of the Regulations and in Article 20 of the Medical Devices Act (ZMedPri-1). The Regulations were adopted with the aim of protecting health and ensuring that only high-quality, safe and compliant devices are placed on the EU market. All devices placed on the EU market must meet the requirements of either Regulation (EU) 2017/745 or Regulation (EU) 2017/746. There is no specific interplay with Regulation (EU) 2023/988 on general product safety, as all requirements applicable to devices are already set out in the Regulations themselves. We also clarify that the requirements apply to all EU Member States. Competent authorities in the EU Member States are facing the same issue.

The information system must be established within one year of the date on which the Medical Devices Act (ZMedPri-1) starts to apply. Its structure and functioning are not yet known; however, it must be compatible with EUDAMED.

As regards the demonstration of competence, manufacturers, manufacturers of custom-made devices and authorised representatives must follow Article 15 of the Regulation, where the requirements are set out. The listed entities must also submit the supporting documentation to the JAZMP. Other entities, namely importers, health institutions and distributors, must meet the competence and qualification requirements set out in Article 20 of the Medical Devices Act (ZMedPri-1).

13.5 What should be done if customs does not recognise the tariff code of a medical device despite its registration in EUDAMED?

JAZMP practice shows that there is continuous communication with customs. In cases of doubt, the JAZMP receives a request for clarification. It should be noted that the use of EUDAMED is not yet legally mandatory; consequently, not all devices placed on the market have been entered into EUDAMED.

13.6 If a medical device is not entered in the EUDAMED register, is the product compliant or not?

The EUDAMED database is not yet fully operational and is used on a voluntary basis. Consequently, it is not to be expected that all devices will already have been entered into EUDAMED. Furthermore, EUDAMED is intended for devices compliant with the MDR and IVDR. Under the transitional provisions of the Regulations, devices compliant with the Directives may still be lawfully placed on the market and will remain on the market until the end of 2028.

The answer is therefore no: if a device is not entered in EUDAMED, this does not mean that it is not compliant. The documentation accompanying the device must be verified.

13.7 We would appreciate a more detailed explanation and information on how the JAZMP will supervise the implementation of individual provisions of the Act in practice.

The JAZMP has been supervising entities in accordance with the Regulations since the application date. Medical Devices Act (ZMedPri-1) regulates only those requirements that must be addressed at the national level. The implementation of both the requirements of the Regulation and those of the Act will therefore be supervised.