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 will enable concerned companies as well as competent authorities to fulfill their registration obligations described in Article 31 of Regulation (EU) 2017/745 ( MDR) and Article 28 of Regulation (EU) 2017/746 (IVDR), respectively .
All economic operators (manufacturers, authorized representatives and importers) must register in EUDAMED prior to the first placing on the market (dispensing against payment or free of charge) of active (energy source dependent) medical devices.
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", which has been released by the European Commission (for link, see "Online procedure").
The Bavarian State Ministry of Health and Care is responsible for monitoring the placing on the market of non-active medical devices, and the governments of Upper Bavaria and Upper Franconia (Pharmacy departments) are responsible as enforcement authorities.
- 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
Links to more information
Responsible for editing:Bayerisches Staatsministerium für Umwelt und Verbraucherschutz
- Online transactions, Bavaria-wide
- Online transactions, locally limited
- Form, Bavaria-wide
- Form, locally limited
- Prefillable Form, Bavaria-wide
- Legal bases, Bavaria-wide
- Legal bases, locally limited
- Fees, Bavaria-wide
- Fees, locally limited