Activities according to Standard Classification of Activities (SCA):
G46.460 – Wholesale of pharmaceutical goods
G47.740 – Retail sale of medical and orthopaedic goods in specialised stores
Registration with the JAZMP
Until EUDAMED is fully functional, importers established in the Republic of Slovenia must register with the JAZMP before commencing activities on the Slovenian market.
Person responsible for regulatory compliance and person responsible for vigilance reporting
- at least one person responsible for regulatory compliance, and
- at least one person responsible for vigilance reporting.
The tasks of the person responsible for regulatory compliance may also be performed by the person responsible for vigilance reporting.
Companies defined as micro and small enterprises are not required to have the 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.
Persons responsible for regulatory compliance and those responsible for vigilance reporting must have appropriate expertise in medical devices, demonstrated by either of the following:
- 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 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 an importer registration must include the following:
- Importer registration form – Form 858-03 must be submitted in its original form 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 IMPORTER 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 the manufacturer is established in a third country (outside the EU), also indicate their authorised representative in the EU.
The data provided in the attachment 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.
- the EU declaration of conformity, and
- the CE Certificate for the medical device.
These documents should be submitted via email to: .
Change of economic operator data:
- the list of medical device manufacturers conducting business with the distributer;
- the category or group of devices;
- the intended purpose of the devices.
Changes relating to the aforementioned three categories must be submitted
- in the attachment (.xlsx): List of medical device manufacturers conducting business with the importer
Deletion of economic operator:
Importers established in the Republic of Slovenia must notify the JAZMP of the cessation of their manufacturing activities no later than eight days after the cessation by submitting the following application:
- 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.
Obligations of importers
- Upon each first placing of a device on the market, importers must provide the JAZMP with documentation demonstrating its conformity, such as a declaration of conformity and a certificate.
- Importers must also notify the JAZMP of any purchases of devices that are to be made available on the Slovenian market.
- Importers must notify the JAZMP of their cooperation with a new manufacturer or termination of cooperation, as well as any changes affecting the device’s compliance.
Importers must retain the Unique Device Identifier (UDI) for the devices supplied to them in electronic form, regardless of the device’s risk class.
Registration in EUDAMED
Economic operators engaged in importing medical devices must register with the European Database on Medical Devices (EUDAMED) to obtain a Single Registration Number (SRN).
- Electronic application: Registration in EUDAMED (Actors Module)
The JAZMP only assigns an SRN to operators who attach the following to Step 4 of the EUDAMED registration:
- A digitally signed declaration: Declaration on Information Security Responsibilities (in PDF format) signed with a qualified digital certificate (SIGEN-CA, SI-PASS, Pošta®CA, AC NLB, or Halcom CA).
If the declaration is hand-signed, the original physical document must be sent to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana.
