Incoming: MHRA consultation on UK Medical Devices Regulations

On 25 September 2024, the MHRA updated its roll-out of the new medical device regulatory framework for Great Britain. The MHRA aims to complete a consultation on certain aspects of the new framework before the end of 2024. With October already upon us, we can only assume that the consultation will be dropping in the next few weeks.

The (very) long-awaited new regulatory framework will modernise the existing Medical Devices Regulations 2002 (UK MDR). The MHRA has stated that the changes to UK MDR will be delivered through four statutory instruments (SIs). The second of these SIs (termed the “Pre-Market SI” by the MHRA) is expected to include the core measures of the new framework, and reflect the 2021/2022 consultation regarding changes to the UK MDR.

Despite having already conducted a lengthy consultation, apparently the MHRA will imminently conduct another consultation in relation to the “measures to improve access” contained in the core SI. Apparently, this is necessary as these measures go further than the contents of the 2021/2022 consultation. While there are few clues regarding the scope of the consultation, it is likely to focus on the proposed international recognition procedures as these did not feature in the last consultation.

The draft policy for international recognition of medical devices was published in July 2024 and represents a hugely significant cornerstone of the new UK approach to regulation of devices. The route was initially pitched as enabling “near automatic” approval of medical devices and therefore many expected that the vast majority of devices commericalised in the UK in future will go via this route.

Industry’s hope for international recognition is that it will involve a true, rapid assessment by the MHRA to allow a certificate of international recognition granting devices access based on approvals issued by trusted international regulators. In order to avoid inevitable delays, the sector is keen that this does not involve an additional review by a UK Approved Body. Whether this will be the case or not, we watch with eager anticipation.