D. Product information
This part of the file contains the product information on the IVD that is part of the performance study.
Depending on the legal framework applicable to the performance study, you are required to submit the following documents:
Performance study falling within the scope of IVDR article 58
- Investigator's Brochure (IB)
- Technical documentation
- Signed statement by the manufacturer (or its authorized representative) about the safety and performance of the IVD
Performance study in the context of post-market performance follow-up (PMPF) studies (IVDR article 70.1)
- Investigator's Brochure (IB) or Instruction for use (IFU)
- EU Declaration of conformity