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 …
Decentralised Manufacturing (DM) is the overarching term used in the UK to cover the two elements of the new manufacturing and supply framework: point of care (POC) and modular manufacturing (MM). A cross-agency team of Quality and Clinical Trial assessors, …
In our September MedTech regulations blog, MHRA Head of Diagnostics and General Medical Devices Joseph Burt seeks stakeholder feedback to two surveys and looks ahead to Autumn updates about the Pre-market statutory instrument, an IVD roadmap and the next IMDRF …
Updates on regulatory reform and plans to support innovation Last month was an incredibly important and exciting month for the UK healthcare system and the Life Sciences sector. July saw the publication of not one, but two pivotal policy documents. …
Marinos Ioannides, Head of Software and AI Medical Devices: If you’re anything like me, Summer in Britain is a season of transformation and hope. Gone are the frozen, damp morning dog walks in darkness. Coats and jackets are locked away, half-empty half-forgotten …
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 …