Division 2.2

for devices intended for the clinical investigations covered by Annex X:

• data allowing identification of the device in question,

• F1the clinical investigation plan,

• F2the 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 7.4 of Annex I,

• a statement indicating whether or not the device is manufactured utilising tissues of animal origin as referred to in Directive 2003/32/EC,

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

• the name of the medical practitioner or other authorized person and of the institution responsible for the investigations,

• the place, starting date and scheduled duration for the investigations,

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