The requirements are outlined in Article 57:
- The device for performance study must comply with the general safety and performance requirements set out in Annex I apart from the aspects covered by the performance study. With regard to those aspects, every precaution must be taken to protect the health and safety of the patient, user and other persons.
- Where appropriate, performance studies shall be performed in circumstances similar to the normal conditions of use of the device.
- The rights, safety, dignity and well-being of the subjects participating in such performance studies must be protected and prevail over all other interests.
- The data generated shall be scientifically valid, reliable and robust.
- Performance studies, including performance studies that use left-over samples, shall be conducted in accordance with applicable law on data protection.
Please consult REK on whether an application to REK is required.