Technical consumer protection; registration of economic operators

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

Description

On 1 December 2020, the European Commission (COM) launched the first of the six planned modules of the European Database for Medical Devices (EUDAMED) for "Actor Registration". This module will allow concerned companies as well as competent authorities to comply with their registration obligations described in Article 31 of Regulation (EU) 2017/745 (MDR).

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

Procedure

The registration of manufacturers, authorised representatives and importers as well as the allocation 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 (pharmaceutical 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: 05.11.2021

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
  • Prefillable Form, Bavaria-wide
  • Legal bases, Bavaria-wide
  • Legal bases, locally limited
  • Fees, Bavaria-wide
  • Fees, locally limited
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