Essentials of European Medical Device Regulatory Affairs

Documents. Annex XV. Chapter II

1.Application form

1.14 startdate and duration 1.15notified body (if already involved in the device) 1.16confirmation that the sponsor is aware the MS may contact the ethics committees 1.17 signed statement by legal manufacturer that device conforms togeneral safety and performance requirements apart from theaspects covered by the  clinical investigation and every precaution hasbeen taken to protect the health and safety of the subject.

2. Investigator’s Brochure

Changes to IBneed tobe provided to the investigators

2.1and 2.2.The Ibdescribes the device, its classification, instructions, information tobe included on the label

2.3preclinical evaluation

2.4existing clinical data

2.5benefit risk and risk management

2.6 information ondevices that include medicinal productsetc.

2.7a list detailing the fulfilment of GSPRasper annex 1.

2.8detailed description of clinical procedures explaining deviation from normal clinical practice

Documents. Annex XV. Chapter II

3.Clinical investigational plan

3.1general

3.1.1 single identification number

3.1.2 sponsor and legal rep name

3.1.3principal investigator details.  The roles and responsibilities of the investigators. 3.1.4 financial arrangements

3.1.5 synopsis in in anofficial language determined by the member state concerned

3.2 ‐3.19protocol like information

4.Other information

4.1 signed statement

4.2ethic committee opinions

4.3 insurance cover

4.4 informed consent

4.5 security ofpersonal information arrangements

4.6 technical document list