The Innovative Devices Access Pathway (IDAP)
Page summary:
The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
Change made:
Updated to add note that iDAP pilot phase and Patient and public engagement in iDAP is now closed.
Time updated:
10:27am, 4 April 2025
AI Airlock: the regulatory sandbox for AIaMD
Page summary:
A proactive, collaborative, agile and the first of its kind approach to identifying and addressing the challenges faced by AI as a Medical Device (AIaMD).
Change made:
Page updated to include a link to a blog about AI Airlock.
Time updated:
1:09pm, 2 April 2025
MHRA showcases next phase of regulatory science to bring innovative treatments to patients sooner
Page summary:
Seven new CERSIs came together to showcase how partnerships will modernise regulation in AI, clinical trials, and advanced therapies, bringing innovations to patients sooner.
Change made:
Photograph from the event added.
Time updated:
9:14am, 1 April 2025
Dame June Raine: How innovations are transforming regulation and speeding new treatments to healthcare
Page summary:
As Dame June Raine gets ready to pass the baton on after nearly 40 years at the agency, the last five of which she has been CEO, she reflects on how new innovations are transforming regulation and how honoured she feels to have worked with such inspiring people through a period she has not just lived through but helped to shape.
Change made:
First published.
Time updated:
3:01pm, 31 March 2025
Exceptional Use Authorisation
Page summary:
How to apply for an exceptional use authorisation to place medical devices on the UK market.
Change made:
First published.
Time updated:
3:50pm, 31 March 2025
Lawrence Tallon begins role as new MHRA CEO
Page summary:
Lawrence Tallon today (1 April 2025) begins his role as Chief Executive Officer of the Medicines and Healthcare products Regulatory Agency (MHRA).
Change made:
First published.
Time updated:
9:03am, 1 April 2025
