Market Intelligence

The European Union's Consumer Protection Cooperation Network has launched coordinated enforcement actions against ten video game companies across 11 games...

Starting January 2027, the Classification, Labelling and Packaging Regulation will explicitly designate distributors as duty holders, fundamentally changing how companies manage Poison Centre Notification requirements across the European Union supply chain. This regulatory clarification particularly impacts businesses that sell mixtures not covered by existing notifications or rebrand products under their own labels. Companies must now assess whether their current compliance framework adequately addresses t

The Court of Justice of the European Union has issued a preliminary ruling in Case C-427/24 Diagramm Halbach, establishing critical principles for determining whether products qualify as medical devices under the EU Medical Device Regulation. The judgment clarifies that manufacturer advertising alone does not determine medical device status, and that products must objectively perform medical purposes to fall within the regulatory definition.

The European Parliament's draft report proposes over 130 amendments to the Commission's plan for overhauling medical device regulations, introducing new categories like "niche" devices while expanding coordination mechanisms between EU authorities. These changes aim to balance regulatory simplification with patient safety, potentially reshaping how medical devices and in vitro diagnostics are classified, assessed, and brought to market across the European Union.

In particular, the Commission held that the platform failed to assess staffing requirements for the review of potentially illegal products, how its advertising systems were contributing to the proliferation of illegal products, and how well its systems prevented the risk of illegal products appearing or being re-listed.

The EU Packaging and Packaging Waste Regulation becomes applicable on 12 August 2026, replacing existing directives with a directly applicable regime governing packaging design, documentation, labelling and end-of-life management across the EU market. Life sciences companies manufacturing medical devices, IVDs and pharmaceuticals face significant compliance obligations, with narrow sector-specific exemptions that do not eliminate core requirements for conformity documentation, substance restrictions...