Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860

MedTech Europe published a template Manufacturer’s Declaration to facilitate the declaration of manufacturers with respect to Regulation (EU) 2024/1860 and:

• The extended transitional periods for devices for which the conformity assessment procedure pursuant to Directive 98/79/EC (IVDD) did not require the involvement of a notified body and/or
• The validity of certificates issued under Directive 98/79/EC (IVDD) (Directive Certificate) 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 In Vitro Diagnostics 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.

Please note that for legacy medical devices, a template Manufacturer’s Declaration in relation to Regulation (EU) 2023/607 can be found on MedTech Europe’s website here.

See the Word template below.