D4. Manufacturer’s statement on safety and performance IVD
In the research file you are required to include a signed statement on the safety and performance of the IVD.
This is laid down in Annex XIV, section 4.1 of the IVDR:
A signed statement by the natural or legal person responsible for the manufacture of the device for performance study that the device in question conforms to the general safety and performance requirements laid down in Annex I apart from the aspects covered by the clinical performance study and that, with regard to those aspects, every precaution has been taken to protect the health and safety of the subject.
You do not need to submit this form for performance studies under article 70.1 of the IVDR. In that case, an EU Declaration of conformity is sufficient.