EU Authorized Representative Services

For manufacturers who are not established in the Union, the authorised representative plays a pivotal role in ensuring the compliance of the devices produced by those manufacturers and in serving as their contact person established in the Union. Given that pivotal role, for the purposes of enforcement it is appropriate to make the authorised representative legally liable for defective devices in the event that a manufacturer established outside the Union has not complied with its general obligations. The liability of the authorised representative provided for in this Regulation is without prejudice to the provisions of Directive 85/374/EEC, and accordingly the authorised representative should be jointly and severally liable with the importer and the manufacturer. The tasks of an authorised representative should be defined in a written mandate. Considering the role of authorised representatives, the minimum requirements they should meet should be clearly defined, including the requirement of having available a person who fulfils minimum conditions of qualification which should be similar to those for a manufacturer's person responsible for regulatory compliance.

Medical Device Regulation 2017/745
What can you expect from EUmediq?
  • EUmediq takes the communication lead during technical file/medical device file inspections by the European Authorities (mainly Germany / bfarm)
  • Notification to the European Authorities
  • Update and monitoring on EUDAMED
  • Represent the manufacturer towards the Commission, Authorities and Notified Bodies
  • Safeguard compliance
  • Complaint handling and postmarket surveillance
  • Companionship to your importers & distributors
Why choose EUmediq as your EU Representative?
  • EUmediq has combined competencies in regulatory, quality and auditing
  • Transparent and fair cost structure
  • Smooth and efficient registration process
  • EUmediq takes care about your goals

Swiss Office
EUmediq GmbH
Thurgauerstrasse 101
8152 Zurich

Place of Jurisdiction:
Registry Court Zurich
Registry ID: CHE-393.275.365

EUmediq GmbH
Mörfelder Landstrasse 6-8
60598 Frankfurt am Main

Place of Jurisdiction: Registry Court Frankfurt a.Main; Registry ID: HRB 119557


© 2020 EUmediq GmbH