MHRA gives extra time to CE marked medical devices By Alison McAdams, Hamza Drabu, Olya Melnitchouk In a welcome announcement, the Medicines and Healthcare products Regulatory Agency (MHRA) has…
Driving innovation and growth in Life Sciences By Alison McAdams, Hamza Drabu, Charlotte Radcliffe After the many challenges that the life sciences and healthcare sectors have faced in recent years,…
Wisely and slow - timetable for UK Medical Device reform delayed By Alison McAdams, Hamza Drabu, Olya Melnitchouk The Medicines and Healthcare products Regulatory Agency (MHRA) has published a decision to…
MHRA publishes medical software and AI roadmap for way ahead By Alison McAdams, Hamza Drabu, Darryn Hale The Medicines and Health products Regulatory Agency (MHRA) has published a roadmap setting out how…
Medical Device Reform – creating a landscape for the future By Alison McAdams, Hamza Drabu, Olya Melnitchouk Following its public consultation on the future regulation of medical devices, the Medicines and…
New template clinical research agreements published by the Health Research Authority By Andrew Johnston, Alison McAdams, Olya Melnitchouk The Health Research Authority (“HRA ” ) has published its eagerly awaited template agreements for…
“Better regulation…for better clinical trials…for better health” – MHRA consultation on the future of UK clinical trials By Alison McAdams, Olya Melnitchouk, Andrew Johnston Clinical trials are a critical element of medical research…
Medical device reform - balancing responsible innovation and patient safety By Alison McAdams, Hamza Drabu, Sean Doherty Following the UK’s departure from the European Union, the UK’s medical devices regulator, the…
Safety concerns about your Philips Ventilator, CPAP and BiPAP devices? - What you need to know By Sean Doherty, Alison McAdams On 23 June 2021 Philips issued two Field Safety Notices (FSNs), warning of the potential for…
The EU Proposal for Regulation of Artificial Intelligence: meaningful steps toward grasping the medico-legal nettle? By Hamza Drabu, Alison McAdams, Jonathan Bonser, Christian Carr On 21 April, the European Commission published its bold proposal 1 for a regulation laying down…
Emerging Technologies – the use of Robotics in surgical procedures By Hamza Drabu, Alison McAdams, Darryn Hale, The use of technology in the healthcare sector is rapidly expanding and continues to play a key…
Product Liability Decision Finds for Pinnacle Metal on Metal Hip Manufacturer By Alison McAdams, Olya Melnitchouk In the much-anticipated Depuy Pinnacle Metal on Metal (MoM) Hip Litigation decision, Mrs Justice…
Clouded judgment: when is software regulated as a medical device? By Alison McAdams, Hamza Drabu, Christian Carr Technology is revolutionising medicine and software is increasingly used in healthcare to help both…
New Code offers product recall guidance By Alison McAdams, Olya Melnitchouk, Stephen Turner Product recall principles set out in new Code The first government-backed Code of Practice for…
Anti-corruption lessons for MedTech companies following first conviction for failing to prevent bribery By Alison McAdams, Anne-Marie Gregory Life science and MedTech companies of all sizes should review their anti-corruption procedures…
Medical device business practice changes: are you ready? By Alison McAdams Manufacturers of medical devices should note the changes being phased in by the Association of…
Investigating Defective Products under the Consumer Protection Act 1987 By Alison McAdams It is not necessary to show how a defect in a product was caused but it is necessary to establish…
The Consumer Protection Act revisited - new light on defective products By Alison McAdams For 15 years, the most thorough examination of when a product is defective, pursuant to the…