D4. Manufacturer’s statement on safety and performance of the medical device

This is laid down in Annex XV, section 4.1 of the MDR:

A signed statement by the natural or legal person responsible for the manufacture of the investigational device that the device in question conforms to the general safety and performance requirements apart from the aspects covered by the clinical investigation 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 clinical investigations under article 74.1 of the MDR. In that case, an EU Declaration of conformity is sufficient.

This statement is desirable but not mandatory for clinical investigations under article 82 of the MDR.