The MDCG (Medical Device Coordination Group) just published a new guidance document on safety reporting in performance studies of in-vitro diagnostic medical devices: MDCG 2024-4.…
What is the difference between a Clinical Study and Clinical Evaluation?
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,…
MDR QMS compliance: Necessary elements by 2024
Manufacturers can benefit from the extended transitional period for legacy devices under certain conditions. One being to have set up a Quality Management System (QMS)…
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…