Category: Regulation & compliance
EU Advocate General Argues That Harmonized Technical Standards Must Be Freely Available
In a case brought by two nonprofit organisations against the judgment of the EU General Court (the EU junior court) upholding the European Commission’s decision refusing to grant access to four harmonized technical standards (HTS), the Advocate General (AG) argued that the Court of Justice of the European Union (the EU senior court) should annul the General Court’s judgment and the European Commission’s decision and order the European Commission to grant the two nonprofit organisations access to the standards.
EU Adopts Restriction of Intentionally Added Microplastics
Emma Bichet and Selma Abdel-Qader
On 25 September 2023, one year after the publication of the proposal, the European Commission adopted the restriction of intentionally added microplastics under the European Union Registration, Evaluation, Authorisation, and Restriction of Chemicals (REACH) Regulation 1907/2006, the EU framework for regulating chemicals
EU Introduces New Carbon Border Adjustment Mechanism
Juan Nascimbene, Emma-Bichet, Fergal Duggan and
Emerald Hockley
The Carbon Border Adjustment Mechanism (CBAM) is a European Union regulation which has been introduced to reduce carbon emissions produced by manufactured goods imported from jurisdictions with less stringent carbon emissions regulations.
EU Puts Red Light on Greenwashing: Agreement Reached on New Laws Targeting Greenwashing
This week, the European Council and Parliament reached provisional agreement on a new European Union (EU) directive to ‘empower consumers for the green transition’.
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 […]
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).