D. Product information
This part of the file contains the product information on the medical device that is part of the clinical investigation.
Depending on the legal framework applicable to the clinical investigation, you are required to submit the following documents:
Clinical investigation in the context of conformity purposes (MDR article 62 and 74.2)
- Investigator's Brochure (IB)
- Investigational Medical Device Dossier (IMDD)
- Signed statement by the manufacturer (or its authorized representative) about the safety and performance of the medical device
Clinical investigation in the context of post-market clinical follow-up (PMCF) investigations (MDR article 74.1)
- Investigator's Brochure (IB) or Instruction for use (IFU)
- Signed statement by the manufacturer (or its authorized representative) about the safety and performance of the medical device or EU Declaration of conformity
Other clinical investigations (MDR article 82)
- Instruction for use (IFU)
- Investigational Medical Device Dossier (IMDD) if the medical device is not CE-marked or is used outside the intended use of the CE-marking
- EU Declaration of conformity if the medical device is CE-marked and used within the intended use of the CE-marking