European Commission Publishes Guidance on Transition from Clinical Trials Directive to Clinical Trials Regulation
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 proposes to up-classify certain beauty equipment falling within EU Medical Devices Regulation
Read our summary on the proposed up-classification of certain products falling within EU Medical Devices Regulation.
Productwise Bitesize brings you a short introduction to the In Vitro Diagnostic Medical Devices Regulation. Since 26 May 2022, this regulation has been applicable to IVDs, and their manufacturers, importers, distributors and online sales at a distance.
Access a recording of the Cooley team’s rapid-fire overview of important changes in EU and US products law.
The UK government has announced it intends to extend the key UKCA and GB importer labelling grace periods, to assist businesses in complying with the post-brexit requirements for products sold in Great Britain.
The hotly-anticipated revision of the European Commission’s Blue Guide has been published. Here’s our take on why this matters to anyone involved in the manufacture, import or sale of products in the EU.
The growth of digital health technologies and artificial intelligence raises novel risks, including data protection and cybersecurity risks, and key questions about the liability of services and software as a product remain unanswered. Wearables are blurring the line between consumer technology and medical devices, and consumer health data has the […]
The online sale of products is under increasing regulatory scrutiny, and the EU’s recently announced draft Digital Services Package promises to alter how online platforms and those who sell through them do business. Join Cooley’s international products law team for the next event in its webinar series, which will feature […]