MedTech Europe has made a template Manufacturer’s Declaration available to facilitate the declaration of manufacturers with respect to compliance with Regulation (EU) 2023/607, allowingmanufacturers to take advantage of the recently announced transition extension timescale for legacy devices.
Any manufacturer may freely use the template to make their own declaration, or it may also be completed by the authorised representative on behalf of the manufacturer. The completed form allows identification of how the manufacturer declares its compliance with the applicable conditions.
The template consists of two parts:
A text part with selectable portions of text as they apply and
A schedule which lists the devices which the manufacturer intends to cover in its Declaration.
The template was jointly developed by AESGP, COCIR, EuromContact, EUROM VI Medical Technology and MedTech Europe.