Division 2.2 F1

For devices intended for clinical investigations covered in Annex 7:

• data allowing the devices in question to be identified,

• the clinical investigation plan,

• the investigator's brochure,

• the confirmation of insurance of subjects,

• the documents used to obtain informed consent,

• a statement indicating whether or not the device incorporates, as an integral part, a substance or human blood derivative referred to in Section 10 of Annex 1,

• the opinion of the ethics committee concerned and details of the aspects covered by its opinion,

• the name of the duly qualified medical practitioner or other authorised person and of the institution responsible for the investigations,

• the place, date of commencement and duration scheduled for the investigations,

• a statement affirming that the device in question complies with the essential requirements apart from the aspects constituting the object of the investigations and that, with regard to these aspects, every precaution has been taken to protect the health and safety of the patient.