Tag: European Commission
The clock is ticking – feedback period for new EU cyber rules ends soon
Claire Temple, Emma Bichet and Selma Abdel-Qader
Productwise guides you through the European Commission’s new initiative on cybersecurity requirements.
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
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
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
Radical Reform of EU Product Liability Laws: Long-awaited Proposals Published
Rod Freeman, Claire Temple, Ed Turtle and Tracey Bischofberger
European Commission publishes long-awaited proposals for reforming EU product liability rules