Transitional arrangements and the future regulation of medical devices in the UK

A press release on the transitional arrangements regarding an extended timeframe for acceptance of CE marked medical devices on the Great Britain market has been published here.

The transitional arrangements aim to ease concerns around disruption to the ongoing supply of medical devices, and so amends the current standstill date of 30 June 2023 in the current UK MDR 2002 and introduce transitional arrangements for CE marked medical devices. The draft Medical Devices (Amendment) (Great Britain) Regulations 2023 have been laid before Parliament accompanied by a draft explanatory memorandum.

Subject to Parliamentary approval, CE marked medical devices will continue to be accepted on the Great Britain market beyond the current deadline of 30 June 2023. The following timelines have been provided by the MHRA:

• general medical devices compliant with the EU medical devices directive (EU MDD) or EU active implantable medical devices directive (EU AIMDD) with a valid declaration and CE marking can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2028;
• in vitro diagnostic medical devices (IVDs) compliant with the EU in vitro diagnostic medical devices directive (EU IVDD) can be placed on the Great Britain market up until the sooner of expiry of certificate or 30 June 2030, and
• general medical devices, including custom-made devices, compliant with the EU medical devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic medical devices regulation (EU IVDR) can be placed on the Great Britain market up until the 30 June 2030.

Regulations 1 to 4 of the Medical Devices (Amendment) (Great Britain) Regulations 2023 are due to come into force on 30 June 2023 and the remainder on 1 July 2023.

Further, the Medicines & Healthcare products Regulatory Agency (“MHRA”) has provided an update on the implementation of the substantial reform of the regulatory framework for medical devices in the UK here. It is expected that the future medical device regulations will broadly reflect the government response to the consultation on the future regulations of medical devices in the United Kingdom published in June 2022.

New guidance is expected to be provided in due course around the intersection of the UK transitional arrangements and the EU’s extended transitional arrangements to give manufacturers more time to get certain medical devices certified under the EU MDR.

The MHRA has produced the following timeline with respect to the future regulatory updates for medical devices:

Our Team of Medical Device and Med Tech Experts here at Bevan Brittan intend to provide further updates once the MHRA puts forward the statutory instruments regarding post-market surveillance and future medical device regulations later this year. It is expected that the regulatory changes to post-market surveillance will affect ‘in-house’ manufacture of medical devices of health institutions and custom-made devices.

How we can help

Our team of regulatory and commercial experts regularly advise clients on the medical devices regulatory framework. We also advise on commercialisation, manufacturing and distribution arrangements. Should you wish to discuss any issues relating to medical device regulation, please contact:

Vincent Buscemi 

Louise Brennan