This document, co-signed by AESGP, COCIR, Eurom, Euromcontact, and MedTech Europe, examines the challenges posed by the five-year recertification requirement set forth in the Medical Device (MD) and In Vitro Diagnostic Medical Devices (IVD) Regulations. It explains how ongoing surveillance, audits, and post-market activities already enable the achievement of the intended safety objectives, thereby rendering fixed-term recertification largely unnecessary and resulting in considerable costs and administrative burdens.
It also includes a comparative table showing how the five-year recertification process duplicates existing lifecycle oversight mechanisms that already ensure the safety and performance of medical devices and in vitro diagnostic medical devices.
MedTech Europe offers an alternative approach:
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Replace the automatic renewal every 5 years with continuous, risk-based monitoring, as already provided for in the MDR/IVDR.
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Limit full re-evaluations to cases where safety signals emerge, substantial changes have occurred, or the evidence requires updating.
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Maintain the certificate’s validity for the duration of the device’s service life, as long as compliance is ensured and the vigilance/PMS mechanisms are operational
View the document: MedTech Europe