1/28/2026 4:35:53 PM A forensic dissection of revised classification Rule 11 – is there any basis for expecting software down classification? By Ellie Handy At the time the Commission published its “Proposal for a regulation to simplify rules on medical and in vitro diagnostic devices”, making...
1/16/2026 2:38:37 PM Medical device simplification in detail: orphan and breakthrough device designations By Jamie Hatzel We wrote recently about the European Commission’s proposals to simplify the EU Medical Device Regulation (“MDR”)[1] and EU In Vitro...
1/16/2026 1:35:54 PM What Top 10 EU And UK Life Sciences Regulatory developments are we following in 2026? By Xisca Borrás There is so much legislative change in the EU and UK in the life sciences sector at the moment that it is sometimes difficult to keep up...
12/22/2025 10:30:42 AM Podcast: Navigating Femtech regulatory compliance in the EU – A legal conversation By Xisca Borrás Ellie Handy Those working in the Femtech space have a difficult regulatory framework to navigate in the EU. For products that qualify as a medical...
12/19/2025 1:34:38 PM The EU pharma package: what we know and what to expect By Xisca Borrás After years in the making, the much-awaited political agreement reached by the EU institutions on the so-called “EU pharma package” will...
12/19/2025 10:12:12 AM European Commission proposes dramatic simplification overhaul of medical device and IVD rules By Jamie Hatzel Xisca Borrás The European Commission has published its long-awaited proposal for a regulation to simplify the EU Medical Devices Regulation (“EU...
12/17/2025 1:23:59 PM European Commission consults on new regulation of medical device and IVD Notified Body activities By Jamie Hatzel The European Commission has recently published a draft implementing regulation under the EU Medical Devices Regulations (“EU MDR”)[1] and...
12/10/2025 9:43:25 AM Podcast: Early-stage funding for FemTech companies in the UK By Sophie Rees Anna Honey Gabriela Necula The FemTech sector, which focuses on technology for women’s health and wellness, is experiencing rapid growth in the UK. Out of the 540...
11/20/2025 9:29:19 AM Podcast: University spin-outs in women’s health innovation By Laura Harwood Melissa Dix In this episode of our Spotlight on Women's Health and Innovation podcast, Laura Harwood and Melissa Dix explore how university spin-outs...
10/22/2025 9:05:01 AM GRUR Annual Meeting 2025: A panel discussion on the infringement of patents with use claims, particularly second medical use claims, in the US, UK, UPC and Germany By Dominic Adair This article was first published in Kluwer Patent Blog [October, 2025]. Coinciding with the 100th year anniversary of the German and UK...
10/21/2025 12:57:12 PM Don’t get lost – How femtech can navigate the EU medical device and AI rules By Xisca Borrás Ellie Handy This article was originally published by Femtech World. Femtech, short for female technology, is an important and fast growing sector....
9/4/2025 8:57:18 AM Breaking Resistance – could AI revolutionise antibiotic discovery? By Claire Smith Using generative AI to discover new antibiotics On 14 August 2025, the Massachusetts Institute of Technology (MIT) reported1 that a team...