Since 2024, the European Commission has been conducting a targeted evaluation of the EU Medical Devices Regulations (MDR and IVDR). The Parliament as well as many Member States have called for a simplification of the regulations, together with business associations from the medical device sector.
From 1 July 2025, the EU will enforce new limits on Homosalate in cosmetics, allowing a max of 7.34% in face products. Reformulation may be required to ensure compliance.
Discover Health Canada’s update requiring a Canadian-based representative for foreign cosmetic brands and how Obelis can help with compliance.
Dutch audits reveal non-compliance with EU post-market surveillance (PMS) requirements for medical devices. Learn how to strengthen PMS systems for compliance and safety.