On 10 July 2023, the European Council voted to approve the Batteries Regulation text. This is the final legislative hurdle for the Batteries Regulation, which will now be translated, signed and published in the Official Journal of the European Union (OJEU) in the next few weeks. The regulation will enter into force 20 days after publication in the OJEU, with the clock beginning to run on a number of important transition periods from that date.
Regulating the Digital Sector, Transforming Consumer Protection Regulation – UK Government Proposes Significant Reforms With Draft Bill
We finally have sight of the long-awaited Digital Markets, Competition and Consumers Bill. Warning: It is a sizeable and ambitious piece of legislation, but the following is our summary take on the key competition and consumer issues.
EMA launches pilot program for expert panel scientific advice in relation to certain high-risk devices
Ten medical device and IVD developers will receive free advice on their clinical development strategies from medical device expert panels. The pilot program aims to help EMA with the implementation of the expert panel advice procedure established in MDR and IVDR.
The European Parliament votes in favor of amending the transitional provisions in the MDR and the IVDR
The European Parliament approves the European Commission’s proposal to extend the transitional periods in the MDR and remove the “sell-off” deadline in the MDR and IVDR.
EMA has decided to restart implementation of its policy to proactively publish clinical data.
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
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 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