New UK CMA Guidance Published – Can Fashion Companies Thread the Needle of Responsible Environmental Claims?
On 18 September 2024, the UK’s Competition and Markets Authority (CMA) published new guidance to explain how fashion retail businesses can navigate their obligations under the UK’s Consumer Protection from Unfair Trading Regulations 2008 and the Green Claims Code when making environmental claims.
The EU’s General Product Safety Regulation: What’s New?
In the first of a series of blogs, the Cooley products team takes a look at what’s new under the European Union’s General Product Safety Regulation.
The EU’s General Product Safety Regulation: Getting Ready for the New Rules With Cooley’s Productwise Blog Series
The European Union’s new General Product Safety Regulation is one of the most important reforms of consumer product safety laws in recent memory. In the run up to its commencement date in December 2024, the Cooley products team will explore the practical implications of the new rules in a series of Productwise blogs.
OECD Guidelines on Responsible Business Conduct: Key Considerations for Multinational Enterprises
The latest updates to the Organisation for Economic Co-operation and Development (OECD) Guidelines for Multinational Enterprises on Responsible Business Conduct in June 2023 thrust supply chain diligence into the spotlight.
Online Safety Act Update
The UK’s Online Safety Act (OSA), which you can read more about in this November 2023 client alert, imposes extensive new obligations on certain types of online service providers. In some cases, the OSA will apply to online marketplaces and certain ancillary services – for example, where user-to-user (U2U) or search services are offered – and there are potential implications in respect of products that may be sold to consumers as a result.
Claire Temple, Carol Holley , Carolina Ljungwaldh and Mo Swart
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.