Medical device CE marking

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

2023-06

MedTech Europe 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 of the above. It may also be completed by the authorised representative on behalf of the manufacturer. The way in which the manufacturer declares their 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
  • A schedule which lists the devices which the manufacturer intends to cover in its Declaration

The template can be downloaded in our library

Source: MedTech Europe