Do you need help navigating regulatory requirements for a medical device? In December 2025, we launched the new MHRA Regulatory Advice Service for medical devices, offering those developing and working with medical devices the opportunity to meet directly with the …
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 …
I remember first hearing about the shared commitment to public involvement when it was announced. I was working in a research department of a hospital, experiencing first-hand how people’s lived experience could drive more inclusive and meaningful health and social …
Large Language Models (LLMs), including ChatGPT and Bard, offer great potential to mimic human conversation. LLMs only directed toward general purposes and whose developers make no claim that the software can be used for a medical purpose are unlikely to …
Last year we updated you on a pilot program to streamline the way clinical trials applications were reviewed in the UK. Working closely with colleagues in the Health Research Authority (HRA) and across the Devolved Administrations we jointly developed a …
Innovation and supporting the research environment in the UK is a key priority for MHRA. But we know we can do more and be even better. You may have read a previous blog on this very topic (Spread the word …
For a number of years now we have been working with the HRA (Health Research Authority), and in partnership with the Devolved Administartions of the UK, behind the scenes to explore opportunities to improve the services we provide to Clinical …
...discussions, even before the non-clinical data is available if that is what will help your development plan. So do not wait, come and talk to us about your plans. We...
...Clinical Trial Submission Type Zip File Name Regulatory Activity (G Code) Initial Clinical Trial H001 - Not Applicable Amendment Clinical Trial H001 - Not Applicable End of Trial Clinical Trial...
March 19th saw the third variations masterclass & workshop (a repeated, single day event) conclude with an overall attendance of 143 delegates from 104 companies. Presentations were held in the morning covering the submission of variation procedures involving Patient Information …
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