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The Manufacturer’s Declaration template is now available on MedTech Europe’s website

Posted on 13.07.2023

MedTech Europe recently published on its website the Manufacturer’s Declaration template, developed in collaboration with AESGP, COCIR, EuromContact, and EUROM VI Medical Technology.

This document is meant to facilitate the manufacturers’ declaration of validity and compliance of certificates issued for Legacy or Active Implantable Medical Devices with the necessary conditions to continue placing them on the market in the context of the transition period extension.

The template may be freely completed directly by manufacturers or by an authorised representative on their behalf.

For further information, please contact Petra Zoellner, Director IVDR – MDR.