All posts by Cooley

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.

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

Productwise Bitesize: The Construction Products Regulation

Jamie Humphreys and Julia Maskell

Productwise Bitesize brings you a short introduction to the Construction Products Regulation (CPR), which sets out the requirements for construction products in the EU.