Technical consumer protection; registration of economic operators

Manufacturers, authorized representatives and importers (importers) of medical devices must register via the electronic system for the registration of economic operators (EUDAMED) before placing a product on the market.

On December 1, 2020, the European Commission (COM) activated the first of the six planned modules of the European Database for Medical Devices (EUDAMED) for "Actor Registration". This module enables the companies concerned and the competent authorities to fulfill their registration obligations as described in Article 31 of Regulation (EU) 2017/745 (MDR) and Article 28 of Regulation (EU) 2017/746 (IVDR) .

All economic operators (manufacturers, authorized representatives and importers) must register in EUDAMED before placing active medical devices (dependent on an energy source) on the market for the first time (supplying against payment or free of charge).

• Required Documents:
  • Document identifying the organization
    • current extract from the commercial register or
    • document assigning the VAT number (Value Added Tax Identification Number) or
    • Document assigning the EORI number (Economic Operators' Registration and Identification number)
  • Information Security Declaration
    The signed Information Security Declaration must be uploaded in EUDAMED as part of the application process.
  • Third country manufacturers only: Summary of the mandate of the authorised representative

The registration of manufacturers, authorized representatives and importers as well as the assignment of the Single Registration Number (SRN) is carried out by the respective competent authority via the EUDAMED module called "Actor Registration" activated by the European Commission (see link under "Online procedure").

The Bavarian State Ministry of Health and Care is responsible for monitoring the placing on the market of non-active medical devices, as are the governments of Upper Bavaria and Upper Franconia (Pharmacy departments) as enforcement authorities.