Update on Medical Device Regulation March 2023

The Medicines and Healthcare products Regulatory Authority (MHRA) has published a press release regarding the impact of the extension of the EU Medical Device Regulations (EU MDR) transitional period and the validity of certificates in the EU.  

We referenced the proposed extension of the transitional periods of the EU MDR in our last update on the Medical Device Regulation: Update on Medical Device Regulation | Bevan Brittan LLP.

The key changes to the EU MDR include:

• Extension of the validity of certificates issued in accordance with Directives 90/38/EEC and 93/42/EEC which have not been withdrawn by a notified body.
• Extension of the transitional period for higher-risk devices (Class III and certain Class IIb implantables) from 26 May 2024 until 31 December 2027, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with notified bodies).
• Extension of the transitional period for medium and lower-risk devices (other Class IIb devices, Class IIa, Class Im, Is and Ir devices) until 31 December 2028, subject to certain conditions (including requirements for market surveillance, quality management systems, and engagement with notified bodies).

These extensions aim to ensure a continued high level of public health protection and an avoidance of a shortage of the medical devices needed for the smooth functioning of healthcare services, without lowering current quality or safety requirements.

It is noted that the MHRA is considering the implications of the extension of the transitional periods for acceptance of CE marked medical devices on the Great Britain market. The MHRA has said it shall publish guidance on the extension of acceptance of the CE marking on the Great Britain market as soon as possible.

The MHRA also refers in its press release to the exceptional use authorisation process in place to enable medical devices to be placed on the Great Britain market in limited circumstances when they do not have a CE or UKCA marking.

The MHRA Press Release can be found here: Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU.

How we can help

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

Vincent Buscemi 

Louise Brennan