All posts by Cooley

EU Batteries Regulation Passes Final Vote

Julia Greaves and Edward Turtle

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

Claire Temple, Caroline Hobson, Anna Caro , Christine Graham and Anushi Amin

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

Elizabeth Anne Wright

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

Elizabeth Anne Wright

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 to reinstate its proactive clinical data publication policy

Elizabeth Anne Wright

EMA has decided to restart implementation of its policy to proactively publish clinical data.

The EMA publishes updated Q&A on clinical trial sponsor oversight of delegated tasks

Elizabeth Anne Wright

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

Jessica Lauren Koffel

Read a summary of the updated version of the Q&A guidance on the Clinical Trials Regulation.