Module 17 2024

05/12/2024

Transition Period

From 1 st January 2021, manufacturers had to register their devices (MD and IVD) with the MHRA. Depending on the device classification, a period of grace was in place (now ended).

CE marking/certification for MDR/IVDR or MDD/IVDD/AIMD under the transitional provisions of the MDR/IVDR from EU-based Notified Bodies will be recognised in GB until the following dates (*this takes into account the MDR extension EU 2023/607):

• General medical devices compliant with MDD 93/42/EEC or AIMDD 90/385/EEC can be placed on the Great Britain market until the expiry of the CE certificateor 30 th June 2028, whichever is earlier.

• In vitro diagnostic medical devices compliant with the IVDD 98/79/EC can be placed on the Great Britain market until the expiry of the CE certificate or 30 th June 2030, whichever is earlier.

• General medical devices, including custom-made devices, compliant with EU MDR 2017/745 and IVDs compliant with EU IVDR 2017/746 can be placed on the Great Britain market until the expiry of the CE certificateor 30 th June 2030, whichever is earlier.

The Organisation for Professionals in Regulatory Affairs

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Transition Period

The legislation allows the placing of self-declared CE-marked Class I medical devices on the GB market beyond 30 June 2023 if they are:

• Self-declared against MDD 93/42/EEC requirements before 26 th May 2021, where Notified Body involvement in their assessment is not required under the MDD but is under the MDR (until 30 th June 2028). This includes up-classified devices and reusable surgical instruments (Class Ir). • The legislation also allows the placing of Class I medical devices which have a sterile (Class Is) or measuring function (Class Im) with a valid MDD 93/42/EEC certificate on the GB market until 30 th June 2028 • Class I devices which do not require Notified Body intervention under either the MDD or MDR have no transition process from the 26 th May 2021. These devices can be self-declared against the EU MDR 2017/745 requirements (until 30 th June 2030) to be placed on the GB market or a self-declaration against the requirements of the UK Medical Device Regulations 2002 if the UKCA mark is to be attached.

The Organisation for Professionals in Regulatory Affairs

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