The AI Airlock is a pilot programme designed to help test and improve the rules for AI-powered medical devices to ensure they reach patients quickly, safely and effectively. Since we announced the pilot cohort in early December, the AI Airlock …
Joseph Burt, Head of Diagnostics and General Medical Devices at the MHRA, speaking at a recent industry forum in Manchester. I hope you are enjoying the lovely early summer sunshine we’re experiencing across the UK and taking a break to …
Medical technologies will play a critical role in delivering the government’s 10 Year Health Plan and its three shifts: hospital to community; analogue to digital; and sickness to prevention. Risk-proportionate regulation, which ensures patient safety whilst supporting innovation and access, …
I’m delighted to be picking up the pen to keep you all informed about the progress of our MedTech regulatory reform programme, and other priorities in the MHRA Innovative Devices team, with this February MedRegs blog. Laura Squire’s departure at …
The International Council for Harmonisation (ICH) M15 Model informed Drug development (MIDD) Guideline has reached Step 2b and is available for public consultation. As a clinical pharmacology assessor at the UK Medicines and Healthcare products Regulatory Agency (MHRA), I was …
We are at that reflective time of year so there will be a lot of that in this edition, but also a seasonal gift in the form of our revised roadmap that sets out a more future view. Some of …
A lot has happened in the month since my last blog, including the launch of the national conversation about the NHS and Budget announcement of additional funding for Life Sciences. This has highlighted the vital role of diagnostics and Med …
Our external engagement on the programme of regulatory changes for medical devices has re-started in earnest this week following the pre-election period and early discussions with new ministers. Bilateral meetings with Trade Associations have begun again, we are speaking at …
Last time I wrote was just before we headed to Washington DC for the 25th Session of the International Medical Device Regulators Forum (IMDRF), hosted by the US Food and Drug Administration (FDA). The first two days were a workshop …
February 2025: We have updated some details in this blog post to reflect changes to the payment system and annual progress reports (APRs). The process for submitting Annual Safety Reports (ASRs) for Clinical Trials of Investigational Medicinal Products (CTIMP) to the …
March 24th marks World TB Day, an important moment to recognise the global effort required to eliminate tuberculosis (TB), a disease that, despite being preventable and curable, continues to be a global health threat. TB does not discriminate, affecting individuals …