Question to the Department of Health and Social Care:

To ask His Majesty's Government what progress they have made in aligning medical device regulations with those of international counterparts, and what impact this alignment is expected to have on patient safety, healthcare efficiency and innovation in the life sciences sector.

Following the Medicines and Healthcare products Regulatory Agency’s (MHRA) Consultation on the future regulation of medical devices in the United Kingdom, we have committed to undertaking full reform of the current regulatory regime for medical devices in the UK. The MHRA’s Roadmap towards the future regulatory framework for medical devices sets out a route to deliver, enabling regulation via a series of new statutory instruments (SIs). Priority measures to protect patient safety will be put in place this year, with core elements of the new framework intended to be in place by 2025. A draft statutory instrument to introduce strengthened post market surveillance requirements is planned to be laid in the first part of 2024. A copy of the roadmap is attached.

Following the announcement on the Chancellor’s Life Sciences Growth package in May 2023, we continue to progress the development of a framework for international recognition, including through targeted engagement with stakeholders, building on the outline proposals for alternative routes to market which were included in our 2021 consultation. The planned regulations are also designed to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances.

Implementing the remainder of the changes outlined in the June 2022 Government response to the 2021 consultation is ongoing. In September 2023, we launched the Innovative Devices Access Pathway as pilot, building the UK offer to innovators of medical devices addressing un-met clinical needs. In the coming year, we also plan to lay further SIs, bringing clarity to industry of the requirements they will need to meet to launch products in the UK in the future. Whilst these changes were outlined in the 2022 government response, we will ramp up our targeted engagement to ensure implementation is done smoothly and in a way that protects ongoing safe supply of products to UK patients.