News Archives - Page 3 of 7

Wooden shelves painted in bright colors hold an assortment of vases and pots, creating a lively and decorative scene.

New Regulation for general products applies from December 2024

From 13 December 2024, the new EU General Product Safety Regulation (GPSR) applies, requiring stricter safety measures and a Responsible Person for all products.

26 September 2024: last call for manufacturers of legacy devices

Ensure your medical devices remain compliant by the upcoming 26 September 2024 deadline. Manufacturers must finalize agreements with notified bodies for MDR CE Certification to retain the legacy status of their devices.

A woman doing research in the laboratory

Extended IVDR legacy period officially published

On 9 July 2024, the Official Journal of the EU published Regulation (EU) 2024/1860, amending the medical devices Regulations (MDR and IVDR). This introduces an extended legacy period for IVDs, effective immediately.

How to carry out clinical investigations of medical devices in the EU

To market medical devices in the EU, manufacturers must provide clinical data specific to the European population.

Kid playing with wooden colorfull blocks

New Toy Safety Regulation and the Digital Product Passport: upcoming changes for the toy industry

The update aims to address shortcomings in protecting children from toy-related risks, notably concerning hazardous chemicals.

The RP Mandate: an essential document for cosmetic compliance

The EU Cosmetics Regulation establishes that only products for which a legal or natural person is designated within the European Union as Responsible Person (RP) can be placed on the market.