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...
10/21/2025 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....
10/21/2025 12:44:04 PM TechBio UK 2025: A view from the conference and beyond By Adam Coughlin On 16 October 2025, Adam Coughlin, Naoise Gaffney and Samuel Munday from Bristows attended TechBio UK, an annual conference hosted by the...
9/18/2025 10:56:35 AM Podcast: Navigating key GDPR challenges in women’s health By Subhalakshmi Kumar Kiran Sidhu In the very first episode of our Spotlight on Women's Health and Innovation podcast, data protection associates Kiran Sidhu and Subha...
9/11/2025 1:21:08 PM $100m Boost for Women’s Health Research By Anna Honey Gabriela Necula Melinda French Gates has announced a $100 million investment into women’s health through a partnership between Pivotal (the coalition...