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
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).
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.
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.
We are one step closer to adoption of the European Union’s new Ecodesign for Sustainable Products Regulation, which is set to have a big impact on several groups of consumer products, as well as intermediates, such as chemicals, iron, steel and aluminium.
On 10 July 2023, the European Council voted to approve the Batteries Regulation text. This is the final legislative hurdle for the Batteries Regulation, which will now be translated, signed and published in the Official Journal of the European Union (OJEU) in the next few weeks. The regulation will enter into force 20 days after publication in the OJEU, with the clock beginning to run on a number of important transition periods from that date.
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 […]
It has been more than a decade since proposals were first made to reform the long-standing General Product Safety Directive (GPSD) in Europe. A lot has happened since then, and as of this week, we now have a new General Product Safety Regulation on the books to replace the GPSD.
Regulating the Digital Sector, Transforming Consumer Protection Regulation – UK Government Proposes Significant Reforms With Draft Bill
We finally have sight of the long-awaited Digital Markets, Competition and Consumers Bill. Warning: It is a sizeable and ambitious piece of legislation, but the following is our summary take on the key competition and consumer issues.
On 19 April 2023, the European Parliament formally approved a new European Union Deforestation Regulation on commodities and products associated with deforestation and forest degradation.