Under the Medical Devices Regulation 2017/745 (MDR), it is required for manufacturers to plan, conduct and document a clinical evaluation. As per Article 61(1) MDR,…
MDCG Guidance on Period Safety Update Report (PSUR) under MDR
Manufacturers of class IIa, class IIb, and class III medical devices have to prepare a Period Safety Update Report (PSUR) for each device or group…