Distributor means any natural or legal person in the supply chain, other than the manufacturer or the importer, which makes a device available on the market, up until the point of putting it into service.
It is important to note that under Regulation 2017/745/EU on medical devices (MDR) and Regulation 2017/746/EU on in vitro diagnostic medical devices (IVDR), pharmacies are also considered distributors if they make medical devices available on the market. The same applies to most opticians.
Activities according to Standard Classification of Activities (SCD)
G47.740 – Retail sale of medical and orthopaedic goods in specialised stores
Registration with the JAZMP
Distributors established in the Republic of Slovenia must register with the JAZMP before commencing their activities on the Slovenian market.
- class I devices not accompanied by instructions for use;
- in vitro devices for which no instructions for use are required or are not provided with the device;
- devices listed by the JAZMP on the basis of expert risk assessment in use, devices that can be made available by economic operators without professional counselling.
Person responsible for regulatory compliance and person responsible for vigilance
- at least one person responsible for regulatory compliance, and
- at least one person responsible for vigilance.
The person responsible for regulatory compliance may also perform the tasks of the person responsible for vigilance.
Distributors are not required to have a person responsible for regulatory compliance within their organisation. However, such a person must be permanently and continuously at their disposal. In this case, the economic operator must verify that the person fulfils the necessary requirements and qualifications.
- A certificate issued by the economic operator demonstrating at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or
- A copy of the contract or another relevant document.
Applications for a distributor registration must include the following:
- The distributor registration form – Form 857-03 must be submitted to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana, either by ordinary post or in person during office hours. The form must be stamped and signed by the person authorised to represent the company.
- Mandatory attachment (.xlsx): List of medical device manufacturers conducting business with the DISTRIBUTER to be submitted by email to .
As an attachment, provide a list of the medical device manufacturers whose devices you distribute. Do not include companies or distributors from which you purchase medical devices. If manufacturers are established in a third country (outside the EU), also indicate their authorised representative in the EU.
The data provided in the attachment (List of manufacturers conducting business with the economic operator) are used for the purposes of implementing Regulation (EU) 2022/123 concerning the crisis-related shortage of medical devices and the situation on the Slovenian market, as well as for the registration procedure and for performing vigilance and incident management relating to medical devices.
Upon receiving a complete application (including the form and all mandatory attachments), the JAZMP will process it. The applicant will receive a digitally signed Certificate of Registration of the Economic Operator via the company’s general email address.
Change of economic operator data
Distributors established in the Republic of Slovenia must notify the JAZMP of any changes to their data (with the exception of the changes relating to the List of medical device manufacturers conducting business with the distributor) by submitting a new application – Form 857-03 no later than eight days after the change is made.
Deletion of economic operator
Distributors established in the Republic of Slovenia must notify the JAZMP of the cessation of the making a device available on the Slovenian market no later than eight days after the cessation:
- Deletion form: Form 861-03
The completed, signed, and stamped form must be submitted to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana, either by ordinary post or in person during office hours.
Distributers must confirm the accuracy of the data referred to in paragraph two of Article 15 of the Medical Devices Act (ZMedPri-1) annually by the deadline specified in the request, which must be at least 30 days long. If they fail to do so, the JAZMP will initiate the procedure for deletion from the register 30 days after the deadline for confirming data accuracy has expired.
