EU Device Registrations
One of the roles and responsibilities of an EU Authorised Representative (EC REP) is to register devices on behalf of the manufacturer.
Therefore, subject to receiving the appropriate fees and documentation your Authorised Representative will register medical devices and/or in-vitro diagnostic medical devices (IVD’s) with a national Competent Authority.
Devices falling under the following classifications must be registered:
- Class I
- Class I Sterile
- Class I Measuring
- Article 12 Procedure Packs/Kits
- Custom Made Devices
- All IVD’s (Including Annex II List A or B)
Under the new regulations (MDR) the newly added classification, Class I re-useable surgical instruments will require registration as such and re-classified IVD’s under the IVDR Class A, B, C & D will also require registration with a national Competent authority.