A new reporting requirement under (EU) 2024/1860 comes into force in a few days’ time, on 10th January 2025. The circumstances for reporting are when: A legal
Overview: PSUR, as outlined in Article 86 of the MDR and Article 81 of the IVDR, is a critical document that provides comprehensive information on the safety,
For medical device manufacturers aiming to comply with the European Union Medical Device Regulation (EU MDR 2017/745), a robust “State-of-the-art” (SOTA) section is crucial for demonstrating clinical
Our Cosmetic Responsible Person team have recently received a number of queries from clients regarding the use of QR codes on their cosmetic product labelling. “Can a
