Category: Regulation & compliance
The Council of the European Union votes in favor of amending the transitional provisions in the MDR and IVDR
The extension of the transitional periods in the MDR and the removal of the “sell-off” deadline in the MDR and the IVDR were approved by the Council of the EU today. The proposed legislative amendment, however, will not enter into force until it is signed by the European Parliament and the Council and published in the Official Journal of the EU.
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.
Nothing lasts forever: Proposed ban of PFAS in the EU
Emma Bichet and Selma Abdel-Qader
The proposed EU restriction of per-and polyfluoroalkyl substances was published on 7 February 2023. If adopted into law, the restriction will result in a ban on the manufacture, use and placing on the EU market of around 10,000 PFAS,
EMA to reinstate its proactive clinical data publication policy
EMA has decided to restart implementation of its policy to proactively publish clinical data.
New applications for approval of clinical trials to be submitted in accordance with the CTR starting on 31 January 2023
Use of CTIS for new clinical trial applications becomes mandatory on 31 January 2023.
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.