Dear Members, MedTech Europe have drafted a manufacturers declaration to Regulation (EU) 2024/1860, the latest IVD regulation transitional legislation. The declaration can be used to support the continued use of IVD Directive Certificates that have expired, but where the manufacturer continues to meet the requirements of the updated legislation and Article 110 of the IVD Regulation 2017/746.
To: Regulatory Affairs Committee IVD; Technical Forum Working Group
Cc: Regulatory Affairs Committee MD (for updated presentation)
Dear Members,
We are pleased to inform you that MedTech Europe has published Manufacturer’s Declaration in relation to Regulation (EU) 2024/1860. It is available on our website https://www.medtecheurope.org/resource-library/manufacturers-declaration-in-relation-to-regulation-eu-2024-1860/. Please feel free to use it and share it with your network.
Background
IVD Manufacturers will have to communicate to different stakeholders (such as Competent Authorities and tenders) about the extended IVDR transition timelines and extended validity of IVDD certificates. The Manufacturer’s Self-Declaration is one of the means to do it. Therefore, MedTech Europe has developed a template for Manufacturer Self-Declaration to support members with the transition. The declaration was developed based on the Manufacturer Self-Declaration jointly developed last year by MedTech Europe and other EU level Medical Device Associations to support manufacturers with respect to Regulation (EU) 2023/607.
Any IVD manufacturer may freely use this template to make their own declaration of compliance with Regulation (EU) 2024/1860 with regards to transitional provisions. 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.
Other means to demonstrate compliance with the new conditions may include Notified Body letter for lodged application, Free Sales Certificate, and Notified Body Agreement.
