Essentials of European Medical Device Regulatory Affairs - June 2020

Documents. Annex XV. Chapter II

1.Application form

1.1 Sponsordetails, or legal rep in EU

1.2manufacturer and AuthorisedRep

Items in red: each MS will review. Article78(3)

1.3 and 1.4 protocoltitle, status (i.e. initial,amendment)

1.5 reference to the clinicalevaluation plan

1.6 explain changes if not initialapplication

1.7 if inparallel to amedicinal product applicationprovide Eudractnumber

1.8 Identify all countries (EU and non EU) involved

1.9 description of the device and its classification

1.10 information ifdevice includesamedicinalproduct or other items e.g. non viabletissues

1.11 summary of the clinical investigation plan (objectives,number and gender, age of subjects) design (controlled)planned dates (start and completion.)

1.12 information on comparator device

1.13 evidence that the clinical investigator and site are capable of conduction the investigation

TheOrganisation for Professionals in Regulatory Affairs

Documents. Annex XV. Chapter II

1.Application form

1.14 start date and duration 1.15 notifiedbody (ifalready involved in the device) 1.16 confirmation that the sponsor is aware theMSmay contact the ethics committees

1.17 signed statement by legalmanufacturer that device conforms to general safety and performance requirements apart from the aspects covered by the clinical investigationand every precaution has been taken to protect the health and safety of the subject. 2. Investigator’s Brochure

Changes to IB need to be provided to the investigators

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

2.3 preclinical evaluation

2.4 existing clinicaldata

2.5 benefit risk and riskmanagement

2.6 information on devices that includemedicinal products etc.

2.7 a listdetailing the fulfilmentofGSPR as per annex 1.

2.8 detailed description of clinicalprocedures explainingdeviation from normal clinicalpractice

TheOrganisation for Professionals in Regulatory Affairs

Documents. Annex XV. Chapter II

3.Clinical investigationalplan

3.1 general

3.1.1 single identificationnumber

3.1.2 sponsor and legal rep name

3.1.3 principal investigator details. The roles and responsibilitiesof the investigators.

3.1.4 financial arrangements

3.1.5 synopsis in in an official language determined by themember state concerned

3.2 -3.19 protocol like information

4.Other information

4.1 signed statement

4.2 ethic committee opinions

4.3 insurance cover

4.4 informedconsent

4.5 security of personalinformation arrangements

4.6 technical document list

TheOrganisation for Professionals in Regulatory Affairs

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