Manufacturer’s Declaration in relation to Regulation (EU) 2023/607 (43 KB)

eurom VI* is making a template Manufacturer’s Declaration available to facilitate the declaration of manufacturers with respect to Regulation (EU) 2023/607 and the validity of certificates issued for Legacy Devices under Council Directive 90/385/EEC or Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC on Medical Devices (MDD) (Directive Certificates) and/or the compliance of the Legacy Devices and their manufacturer with the conditions for the continued placing on the market and putting into service. Any manufacturer may freely use this template to make their own declaration on the points mentioned. *This template was jointly developed by AESGP, COCIR, EuromContact, eurom VI Medical Technology and MedTech Europe. The manufacturer or authorised representative takes their own responsibility when using or adapting the form. eurom VI does not take any responsibility for the content of the template or its terms and its use by the manufacturer or their authorised representative. 2023-06-26