Authorised Representative (MEDICAL DEVICES)

For medical devices and in vitro diagnostic medical devices (IVDs), now the UK has left the EU. Manufacturers must appoint a UK-based Responsible Person or an EU Authorized Representative as there is no longer any mutual recognition.

In order to place devices on the EU market, manufacturers with an Authorized Representative based in the UK will need to establish a new Authorized Representative in an EU country, an complete the necessary registrations of your products.

There are some grace periods for registration based on the device classification. We have developed 2 short videos explaining the new requirements for Great Britain and Northern Ireland.

COUNTRIES COVERED