Declaration of Conformity Template - IVDR 2017/746

Declaration of Conformity Template - IVDR 2017/746

The declaration of conformity is a statement made and signed by the legal manufacturer that they have met all the regulatory requirements stated within the regulation. This template meets the required information needed on a declaration of conformity to medical device regulation EU 2017/746.

The Declaration of Conformity for IVDR is an important document that is often required to demonstrate to regulatory auhthorities when registereing IVD products. The Declaration of Conformity is required to be uploaded onto the EUDAMED system for EU market access. 

If you would like further information on our wide range of templates or have any suggestions for improvement that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at qmsregs@patientguard.com.

IVD Regulatory Support:

If you are looking for support with your IVD compliance then Patient Guards consultancy services could be a cost effective solution for your organisation.