D2. Instruction for use
For post-marketing performance follow-up (PMPF) in the context of IVDR article 70.1, you are required to submit the Instruction For Use (IFU) of the relevant CE-marked IVD 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 IVD is CE-marked and used in accordance with the application of the granted CE-marking:
- EU Declaration of conformity
- Label CE-conformity certificate