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
We are only a few days away until the first critical deadline (26th May 2024) for legal manufacturers of legacy devices (class I up classified devices or
