The Brexit registration grace period has ended

The deadline to appoint a UK Responsible Person (UKRP) and register your medical devices and IVDs was December 31, 2021. If you have not done so yet, you are out of compliance if still placing devices onto the market.

UKCA Marking is required by July 1, 2023 to continue selling medical devices and IVDs in Great Britain.

Deadlines to appoint a CH-REP, Swiss Authorized Representative:

Class IIb implantable, class III, and AIMD – 31 December 2021, Class IIb non-implantable, class IIa – 31 March 2022

Class I, systems and procedure packs – 31 July 2022, Class D IVDs – 31 December 2022, Class C, B IVDs – 31 March 2023, Class A IVDs – 31 July 2023

Lowest risk devices (Class A non-sterile) must comply with the IVDR on its date of application: 26 May 2022

Have you amended your IVDD technical documentation file to be IVDR compliant? Do you know the process and timing to re-register your IVDs?

The IVDR is mandatory in the European Union, Iceland, Liechtenstein, Norway, Northern Ireland, Switzerland and Turkey.