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
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.
Productwise Bitesize: New EU rules on cybersecurity adopted under the Radio Equipment Directive
Productwise Bitesize brings you a short introduction to the Delegated Act to the Radio Equipment Directive on cybersecurity, which aims to increase the level of cybersecurity of wireless devices placed on the EU market.
One Charger to Rule them All! European Commission, Council and Parliament Reach Agreement on Common Chargers Proposal
Edward Turtle and Julia Maskell
The European Commission and Parliament have reached an agreement on the proposal to introduce a common USB-C charger for many electrical products in the EU. Productwise brings you what we know so far.
Productwise Bitesize: The Radio Equipment Directive 2014/53/EU
Jamie Humphreys and Julia Maskell
Productwise Bitesize brings you a summary of the Radio Equipment Directive, a key piece of EU legislation applicable to any products with WiFi or Bluetooth functionality.