EU Study Investigates Different Models for Directly Shipping Drugs to Patients
On 12 July 2023, a study was published in the British Journal of Clinical Pharmacology on different models in Europe for directly shipping drugs to patients during decentralized clinical trials (DCTs ), which are conducted in environments such as a participant’s home or a local address, rather than investigative sites. […]
European Commission Adopts Directive Extending Time Lead can be used in PVC sensors of IVDs
The European Commission has adopted Commission Delegated Directive (EU) 2023/1526, which amends Directive 2011/65/EU of the European Parliament and European Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride (PVC) used as base material in sensors for in vitro diagnostic medical devices (IVDs). Directive 2011/65/EU […]
Long-Awaited Mandatory EU ESG Reporting Standards Adopted
The European Commission has now adopted the sustainability reporting standards that will be mandatory for companies in-scope of the European Union’s Corporate Sustainability Reporting Directive (CSRD). For full insight into the mandatory ESG reporting Standards the full article can be found here. Please reach out to our team if you […]
UK Product Safety Review Power Briefing Webinar
Join Cooley’s International Products Team for a 30 minute overview and discussion of the key proposals contained in the UK’s long awaited Product Safety Review and their potential impact on those doing business in the UK.
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 Its Proposed New Toy Safety Regulation
Edward Turtle and
Tracey Bischofberger
The European Commission published its legislative proposal to revise the Toy Safety Directive on 28 July 2023. This long-awaited proposal follows the evaluation of the Toy Safety Directive published in 2020 that identified a number of areas where it was thought that the existing rules could be strengthened. The draft legislation includes proposed reforms we expect could influence other European Union sector-specific product rules, such as proposed requirements for a Digital Product Passport to provide certain compliance information.
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).
UK Product Safety Review Finally Published – and Contains Some Surprises
Claire Temple , Ed Turtle , Rod Freeman and Tracey Bischofberger
On 2 August 2023, the UK government published its long-awaited proposals for reform of the UK product safety regime. There are 13 wide-ranging proposals, some of which could radically change the UK product safety landscape and/or have a significant impact for stakeholders.
UK Government Announces ‘Indefinite’ Extension of CE Marking Recognition for 18 Categories of Goods
Rod Freeman , Claire Temple , Edward Turtle and Tracey Bischofberger
On the 1st August the UK government announced plans to extend recognition of CE marking ‘indefinitely’ beyond the upcoming December 2024 legislative deadline for certain products placed on the Great Britain market (England, Wales and Scotland). This announcement means that the UK Conformity Assessed (UKCA) mark will no longer be required on many products, which is a significant change of position from the UK government. The details – including how divergence will be accommodated – are not yet clear, so there are a number of unanswered questions. However, read on for what we know so far.