D2. Instruction for use
For post-market clinical follow-up (PMCF) studies under MDR article 74.1 and for investigator-initiated studies with a CE-marked device under MDR article 82, you are required to submit the Instruction For Use (IFU) of the relevant CE-marked medical device as part of the research file.
In addition to the IFU, you are required to submit at least one of the following documents (if available) to demonstrate that the medical device is CE-marked and used in accordance with the application of the granted CE-marking:
- EU Declaration of conformity (MDR article 74.1/82)
- Label (MDR article 74.1)
- CE-conformity certificate (MDR article 74.1)
- Clinical Evaluation Report (CER) (MDR article 74.1)