Well, hello again. Hasn’t time passed by so quickly since my last blog in September. At the MHRA, we have many exciting and pioneering initiatives underway. I was listening to a medical device podcast recently and the podcast host proclaimed …
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 …
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 …
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 …
Welcome to the March issue of the Med Tech Regulatory Reform blog series. As the leader of a team which includes many talented female scientists, I am particularly delighted to be publishing this at the start of British Science …