Authorised representative means any natural or legal person established within the European Union who has received and accepted a written mandate from a manufacturer, located outside the Union, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under this Regulation. Where the manufacturer of a device is not established in a Member State and does not have an authorised representative in a Member State, their device may not be placed on the Union market.
Activities according to Standard Classification of Activities (SCD)
C32.500 – Manufacture of medical and dental instruments and supplies
Registration with the JAZMP
Until EUDAMED is fully functional, authorised representatives of manufacturers established in the Republic of Slovenia must register with the JAZMP before commencing their activities on the Slovenian market.
Applications for the registration of an authorised representative must include the following:
- Authorised representative registration form (Form 855-01)
- Mandatory attachments:
- Documentation demonstrating the appropriate qualifications of at least one person who is responsible for regulatory compliance and has the required expertise in medical devices in accordance with Article 15 of Regulation 2017/745/EU and Article 15 of Regulation 2017/746/EU, as follows:
- A diploma, certificate or other evidence of formal qualification, awarded upon completion of a university degree or a study programme recognised by the Member State concerned as equivalent 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; or
- Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.
- A valid written mandate between the manufacturer established outside the EU and the manufacturer’s authorised representative in the EU.
Micro and small enterprises, within the meaning of Commission Recommendation 2003/361/EC, 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.
The completed, signed and stamped form, together with the mandatory attachments, must be submitted to the following address: JAZMP, Slovenčeva ulica 22, 1000 Ljubljana, either by ordinary post or in person during office hours.
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
Authorised representatives established in the Republic of Slovenia must notify the JAZMP of any changes to their data by submitting a new application no later than eight days after the change is made.
Deletion of economic operator
Authorised representatives established in the Republic of Slovenia must notify the JAZMP of the cessation of their 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.
Registration in EUDAMED
Economic operators engaged in the manufacturing of 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 5 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.
Medical device registration
Instructions on registration of medical devices are published here: Registration of medical devices – JAZMP.
