All posts by Cooley

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.

Productwise Bitesize: New EU rules on cybersecurity adopted under the Radio Equipment Directive

Emma Bichet and Fergal Duggan

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.