PFAS Regulation: EPA Designates Two PFAS as Hazardous Substances Under CERCLA
On April 19, 2024, the US Environmental Protection Agency (EPA) issued a final rule that designates two PFAS chemicals – PFOA and PFOS – as ‘hazardous substances’ subject to the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA, also known as Superfund). The rule will take effect under CERCLA, giving the EPA increased authority to investigate and respond to PFAS contamination and seek recovery of costs associated with cleanup efforts. The EPA sees the new rule as a significant step in its regulation of PFAS.
European Commission Publishes Guidance on Transition from Clinical Trials Directive to Clinical Trials Regulation
Elizabeth Anne Wright , Jessica Lauren Koffel and Alix Vermulst
On 19 July 2023, the European Commission published a guidance document concerning the steps to be taken in the transition of clinical trials from the Clinical Trials Directive (CTD) to the Clinical Trials Regulation (CTR).
European Commission Publishes MDR and IVDR Factsheet for Non-EU/EEA Countries
Elizabeth Anne Wright , Jessica Lauren Koffel and Alix Vermulst
On 12 July 2023, the European Commission published a factsheet for authorities outside the European Union (EU) and the European Economic Area (EEA) on the implications of the extended deadlines in Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).
UK Government Provides Limited Extensions to Recognition of CE Marks for Medical Devices in Great Britain
Elizabeth Anne Wright , Jessica Lauren Koffel and Alix Vermulst
On 1 August 2023, the UK government announced plans to extend recognition of CE marking ‘indefinitely’ for certain products placed on the Great Britain market (England, Wales and Scotland).
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.
GCP Q&A Clarifies Sponsor Role in Trial-Related Tasks, Provides Other Updates
The European Medicines Agency (EMA) has updated its Q&A for good clinical practice (GCP). The update acknowledges that the sponsor may support the investigator by identifying or contracting service providers in the conduct of the clinical trial. This update reflects the leading role of sponsors in interaction with contracting service […]
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
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 to reinstate its proactive clinical data publication policy
EMA has decided to restart implementation of its policy to proactively publish clinical data.