Medicines Healthcare Products Regulatory Agency
Overview
On 26 June 2022, MHRA published thegovernment response to the public consultation on the future regulation of medical devices in the United Kingdom. The response outlined the intended regulatory reform including the transitional arrangements for CE marked devices placed on the Great Britain market which were put in place in 2023.
On 9 January 2024, the MHRA released a Roadmap towards the future regulatory framework for medical devices. This provides an update on the intended timelines to implement the future core regulations.
On 21 May 2024, following on from stakeholder discussions throughout the first quarter of 2024, MHRA released a statement of policy intent for recognition by the UK of approvals of medical devices from international regulators. This statement sets out MHRAs proposed policy approach. The final legal text would come into force at the same time as the future core regulations.
Contact
For further information, please email our Customer Services Centre atinfo@mhra.gov.ukor call 020 3080 6000. Alternatively, contact your Trade Association by emailing:
- Association of the British HealthTech Industries (ABHI):enquiries@abhi.org.uk
- British In Vitro Diagnostics Association (BIVDA):enquiries@bivda.org.uk
- Proprietary Association of Great Britain (PAGB):regulatory@pagb.co.uk
- The British Healthcare Trades Association (BHTA):info@bhta.com
- UK Responsible Persons Association (UKRPA):enquiries@ukrp-association.org