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).
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 […]
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.
Productwise Bitesize: In Vitro Diagnostic Medical Devices Regulation
Alexander Wenzel and Jessica Koffel
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.
Productwise Bitesize: Low Voltage Directive
Jamie Humphreys and Harriet Jones
Productwise Bitesize brings you a short introduction to the Low Voltage Directive, a key piece of EU legislation setting out health and safety standards for electrical equipment.
Rapid-Fire Update on International Developments in Products Law: Webinar Recording
Access a recording of the Cooley team’s rapid-fire overview of important changes in EU and US products law.
WEBCAST: Rapid-Fire Update on International Developments in Products Law
Tune in for a 30-minute rapid-fire webinar on recent developments in product regulation and product liability in the EU and US.
UK Government Announces Extension to Key UKCA Grace Periods
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.