01 Mar, 2024 MHRA grants first medicine approval via the new International Recognition Procedure By Jamie Hatzel For the very first time, the MHRA has a granted a UK marketing authorisation (UKMA) for a medicine through its new International...
21 Feb, 2024 Will it be possible to lawfully test an AI Medical Device? By Alex Denoon A brief analysis of the interaction between the proposed AI Act and the MDR The AI Act continues to contain a concerning flaw as regards...
29 Jan, 2024 Implementation deadlines for the EU In Vitro Diagnostic Medical Device Regulation further postponed By Alex Denoon Melissa Dix Extending the transitional periods for implementation A considerable number of in vitro diagnostic medical devices (IVDs) currently on...
23 Jan, 2024 UK MDR: further delays, unexpected developments? - Bristows By Alex Denoon Jamie Hatzel On 9 January 2024, the MHRA published a new Regulatory Roadmap, which sets out the expected timeline and key milestones on the way to the...
18 Jan, 2024 Publication: Biotech Review of the Year By Gregory Bacon Xisca Borrás Will Hewitt 2023 is likely to be remembered as a year in which a number of highly anticipated developments in the biotech industry finally came to...
10 Jan, 2024 Podcast: In conversation with AstraZeneca By Vik Khurana In this episode of our digital transformation podcast - The Roadmap - I was joined by two very special guests, Adam McArthur and Warren...
02 Nov, 2023 Tech M&A podcast: First two episodes now available By Julia Cockroft Chris Devlin Jamie Hatzel Sophie Rees +1 more... Show less In line with the UK’s bid to become a global leader in innovation, we are seeing an increased focus on deals driven by pioneering...
12 Oct, 2023 Podcast: Full Disclosure By Jamie Hatzel Vivien Zhu These three podcasts will provide what you need to know about the UK government consultation on disclosure of transfers of value to the...
25 Sep, 2023 MHRA simplifies legal representative requirements for clinical investigations in Northern Ireland By Jamie Hatzel Since Brexit, the UK has been subject to two separate regulatory frameworks on medical devices. Great Britain is subject to the Medical...
21 Sep, 2023 The Innovative Devices Access Pathway – expediting access to MedTech By Alex Denoon Jamie Hatzel
18 Sep, 2023 First CRISPR therapy seeks regulatory approval, but will it be able to avoid the pitfalls of other cell and gene therapies? By Janna Lawrence Claire Smith Ellen Lambrix This article discusses the first CRISPR therapy seeks regulatory approval, raising the question but will it be able to avoid the pitfalls...
18 Sep, 2023 DHSC consults on statutory disclosure of industry payments to the healthcare sector By Alex Denoon Jamie Hatzel Alex Denoon, Chris Bates and Jamie Hatzel discuss the UK government's proposed statutory regime