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.
European Commission publishes updated Q&A on the Clinical Trials Regulation
Read a summary of the updated version of the Q&A guidance on the Clinical Trials Regulation.
The NIS 2 Directive establishes new cybersecurity requirements for medical device manufacturers
Elizabeth Anne Wright and Alexander Wenzel
Cybersecurity requirements established in the NIS 2 Directive apply to medical device manufacturers
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
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
New EU liability rules proposed for artificial intelligence
Rod Freeman, Claire Temple, Jamie Humphreys and Tracey Bischofberger
European Commission publishes new liability rules to simplify claims for damage caused by AI-systems
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.
Microplastics, big impact: New EU proposal to restrict microplastics
Selma Abdel-Qader and Emma Bichet
On 30 August 2022, the European Commission published its long-awaited proposal to restrict the placing on the market of microplastics, including where they are added to certain products. The restriction will be adopted under the REACH Regulation, which establishes the EU chemicals framework.
European Commission proposes to up-classify certain beauty equipment falling within EU Medical Devices Regulation
Elizabeth Anne Wright , Emma Bichet and Alexander Wenzel
Read our summary on the proposed up-classification of certain products falling within EU Medical Devices Regulation.