In October, the Health and Youth Care Inspectorate (IGJ), the Dutch authority overseeing medical devices, called on manufacturers to ensure their PMS systems meet MDR requirements. The IGJ emphasized the need for continuous monitoring to safeguard device safety.
Since the MDR took effect in May 2021, compliance with its PMS requirements is mandatory. However, recent IGJ inspections at 13 companies revealed significant gaps in compliance. Many manufacturers appear to undervalue PMS, missing critical aspects necessary for a compliant system.
The MDR outlines clear yet comprehensive requirements for PMS, specifying what the PMS plan and related technical documentation should encompass.
Are you confident your PMS system is MDR-compliant? If you’re unsure, Starodub offers a full range of PMS services and can be your reliable partner in achieving compliance. Contact us to learn more!
