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.
New EU liability rules proposed for artificial intelligence
Rod Freeman, Claire Temple, Jamie Humphreys and Tracey Bischofberger
European Commission publishes new liability rules to simplify claims for damage caused by AI-systems
Productwise Bitesize: Toy Safety Directive
Edward Turtle and Carol Holley
Cooley’s Productwise Bitesize brings you a short introduction to the Toy Safety Directive.