European Commission publishes updated Q&A on the Clinical Trials Regulation
Read a summary of the updated version of the Q&A guidance on the Clinical Trials Regulation.
The European Commission publishes a proposal to amend the transitional provisions foreseen in the Medical Devices Regulation and the In Vitro Diagnostic Medical Device Regulation
Elizabeth Anne Wright and Jessica Lauren Koffel
Read an overview of the proposed amendments to the transitional provisions of the MDR and the IVDR.
Medical devices and IVDs fall outside the scope of the proposed CRA – but for how long?
Elizabeth Anne Wright and Alexander Wenzel
The medical device industry is out of scope of the proposed Cyber Resilience Act
The NIS 2 Directive establishes new cybersecurity requirements for medical device manufacturers
Elizabeth Anne Wright and Alexander Wenzel
Cybersecurity requirements established in the NIS 2 Directive apply to medical device manufacturers
What a year! So what next in 2023?
Rod Freeman and Tracey Bischofberger
2022 has been a really big year for products law across the globe, with a raft of significant new measures published. Productwise brings you a round-up of the highlights from 2022 and what to look out for in 2023
Risks through a new PRISM – UK safety regulator unveils new risk assessment methodology
Rod Freeman, Jamie Humphreys and Tracey Bischofberger
OPSS publishes PRISM – a new approach to risk assessment in the UK
European Commission proposes extension of the transition periods foreseen in the Medical Device Regulation
Read our update on the extension of the transition periods in the Medical Device Regulation
New European Manual on Borderline Classification for medical devices and IVDs
Jessica Koffel and Alexander Wenzel
Read our short overview of the New European Manual on Borderline Classification for medical devices and IVDs
Webinar: New Liability Risks
Join Cooley’s international products law team today for a rapid-fire webinar covering new liability risks for product stakeholders.