EU representation is a requirement for all manufacturers established outside the EU, without any physical presence (i.e., address) in an EU country.
Which countries are affected by the EU Authorised Representative requirement?
All manufacturers established in countries outside Europe should appoint an Authorised Representative, to ensure compliance with the MDR/IVDR requirements.
The requirement for appointment of an EU Authorised Representative also applies to manufacturers based in any European country that is not part of the EU (including the UK after Brexit).
The EU-Switzerland Mutual Recognition Agreement (MRA) for Medical Devices ceased to apply on May 26, 2021, when the EU MDR came to force. Similarly, the MRA for in vitro diagnostics ceased to apply on May 26, 2022, day of IVDR application. As a result, manufacturers placed in Switzerland are from those dates onwards treated as “third country” manufacturers and are required to also appoint an EU Authorized Representative in order to place their products in the EU market.
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