For the purpose of facilitating manufacturer’s declaration, EuromContact* is making a template Manufacturer’s Declaration available, with respect to Regulation (EU) 2023/607 and :
Any manufacturer freely may use this template to make their own declaration of the above. It may also be completed by the authorized 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:
* This template was jointly developed by AESGP, COCIR, EuromContact, EUROM VI and MedTech Europe.
The manufacturer or authorised representative takes their own responsibility when using or adapting the form. EuromContact does not take any responsibility for the content of the template or its terms and its use by the manufacturer or their authorised representative.