Brussels, 5 November 2025 – This document, co-signed by AESGP, COCIR, eurom, Euromcontact and MedTech Europe, examines the challenges posed by the five-year re-certification requirement under the EU Medical Devices Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). It explains how continuous monitoring, audits, and post-market activities already achieve the intended safety objectives, making fixed-period re-certification largely redundant while adding significant administrative burden and cost.
The document is structured as a clear series of questions and answers, complemented by a visual depiction of the continuous surveillance system currently in place under the MDR and IVDR. It also includes a comparative table showing how the five-year re-certification process duplicates existing lifecycle oversight mechanisms that already ensure the safety and performance of medical devices and IVDs.
Our industry stands ready to work with the European Commission, Member States, and stakeholders to co-create practical solutions that secure faster and continued access to safe and effective medical technologies, strengthen Europe’s health systems, embrace digitalisation and foster trust in a future-ready regulatory framework.
Document
Please consult the full paper to learn more: