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.

Description

Procedure

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").

Special notes

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.

Required documents

  • 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

Forms

Online procedures

Links to more information

Status:22.09.2023

Responsible for editing:Bayerisches Staatsministerium für Umwelt und Verbraucherschutz

Contains machine translated content. Show the original content

  • 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
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