ACTOR REGISTRATION MODULE
- authorised representatives
- manufacturers of systems and procedure packs
must also register in the EUDAMED European database and obtain a SRN before putting a non-custom-made device on the market.
Registration is done via: EUDAMED REGISTRATION
Economic operators acting solely as distributors (undertake activities of distribution) of medical devices do not register in EUDAMED. However, they must register in the national register at the JAZMP over the SPOT portal: registration on the SPOT portal.
Currently, registration is carried out on a voluntary basis. After registration has been confirmed by the JAZMP, the economic operator is assigned a single registration number in accordance with Article 31 of the Regulation (EU) 2017/745 on medical devices.
Please note! The JAZMP only verifies operators with an appropriate digitally signed statement (Declaration on Information Security Responsibilities) or hand-signed statement by the responsible person sent to JAZMP, Slovenčeva ulica 22, 1000 Ljubljana.
You can find the instructions and important steps for the successful registration of economic operators in EUDAMED here.
To facilitate registration for Slovenian economic operators, we prepared a document with frequently asked questions and answers. To view, click here.
To access the clarifications and instructions for the registration and verification of other EUDAMED users connected with individual economic operators (EUDAMED: Economic Operator user guide)
The public part of EUDAMED (the search engine) with information on registered economic operators is also accessible here – EUDAMED SEARCH ENGINE.