📢 MedTech Europe* makes available a Manufacturer Declaration template to facilitate manufacturers’ declarations with respect to Regulation (EU) 2023/607 and:
- The validity of certificates issued for Legacy Devices under Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) or Council Directive 93/42/EEC concerning Medical Devices (MDD) (Directive Certificates) and/or- The compliance of “Legacy” Devices and their manufacturer with the conditions for their continued placing on the market and putting into service. Any manufacturer may freely use this template to make its own declaration of the above. It may also be completed by the authorised representative on behalf of the manufacturer. The way in which the manufacturer declares its compliance with the applicable conditions is disclosed by the manufacturer in the completed form.
The template consists of two parts:
- A text part with selectable portions of text as they apply, and- an annex listing the devices that the manufacturer intends to cover in its Declaration. * This template was developed jointly by AESGP, COCIR, EuromContact, EUROM VI Medical Technology and MedTech Europe. The manufacturer or authorised representative assumes its own responsibility when using or adapting the form. MedTech Europe assumes no responsibility for the content of the template or its terms and its use by the manufacturer or its authorised representative.
You can download the document here:
https://www.medtecheurope.org/wp-content/uploads/2023/06/230609-final_mdr_manufacturer-declaration.docx