Category: Regulation & compliance
New EU rules on the design and production of batteries published
Ed Turtle, Tracey Bischofberger and Selma Abdel-Qader
After lengthy negotiations, the ‘final’ text of the EU Batteries Regulation agreed between the European Commission, Parliament and Council has been published. Whilst it’s possible there could still be minor changes, you can expect this to be substantively the same as the final published legislation.
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.
EMA guideline on sponsor responsibility for release and shipping of IMPs in accordance with GCP and GMP in the EU comes into effect
Read an overview of the EMA guideline on clinical trial sponsor responsibility for management of IMPs
The EMA publishes updated Q&A on clinical trial sponsor oversight of delegated tasks
Read a summary of EMA’s updated guidance on how clinical trial sponsors can demonstrate oversight of activities delegated to third party service providers.
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