Sep 25, 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...
Sep 21, 2023 The Innovative Devices Access Pathway – expediting access to MedTech By Alex Denoon Jamie Hatzel
Sep 18, 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...
Sep 18, 2023 DHSC consults on statutory disclosure of industry payments to the healthcare sector By Alex Denoon Christopher Bates Jamie Hatzel Alex Denoon, Chris Bates and Jamie Hatzel discuss the UK government's proposed statutory regime
Aug 31, 2023 A Turing Test for Embryos? By Julian Hitchcock Philip Ball writes on an important contribution to the discussion on the twilit zone between human embryo models and actual human...
Aug 23, 2023 A deep dive on new UK post-market surveillance rules By Jamie Hatzel The UK government recently released a draft copy of a statutory instrument which will introduce new post-market surveillance (PMS) rules...
Aug 17, 2023 Proposed review of the statutory scheme: a sign of things to come in VPAS? By Alex Denoon Vivien Zhu The Department of Health and Social Care (DHSC) recently announced a consultation for a review of the statutory scheme for branded...
Aug 17, 2023 New UK Approved Bodies appointed for medical devices By Alex Denoon Vivien Zhu The MHRA has appointed two new UK Approved Bodies for medical devices, namely the UK affiliates of EU Notified Bodies TÜV Rheinland and...
Jul 28, 2023 New UK post-market surveillance rules for medical devices released By Jamie Hatzel The UK government recently released the text of a new draft statutory instrument (SI) which will update the post-market surveillance...
Jul 11, 2023 Curtain raised on New Genomic Techniques Regulation By Julian Hitchcock European Commission proposes to ease the regulatory burden for gene-edited plants. But when will it become law, and in what form? The...
Jun 29, 2023 “Synthetic Embryos”: What's in a name? By Julian Hitchcock "Synthetic Embryos" are neither Synthetic nor Embryos. So why are editors giving that name to stem cell-based models of human...
Jun 23, 2023 Stembryos: Project launched to provide guidance on research using synthetic embryo models By Hugo Kent-Egan This week a project was launched to develop the first governance framework for research involving stem cell-based embryo models (SCBEMs)...