Essentials of European Medical Device Regulatory Affairs

Documents - Annex XV. Chapter II

1.Application form

1.1Sponsordetails,or legal rep inEU

1.2manufacturerand AuthorisedRep

Items in red: each MS will review. Article 78(3)

1.3and1.4protocoltitle,status (i.e. initial,amendment)

1.5 referenceto theclinicalevaluationplan

1.6explainchanges ifnot initialapplication

1.7 if inparallel toamedicinalproductapplicationprovide Eudractnumber

1.8 Identifyall countries (EUand nonEU) involved

1.9descriptionof the deviceand itsclassification

1.10 information if device includesamedicinalproductorother itemse.g.nonviabletissues

1.11summaryof theclinical investigationplan (objectives,numberandgender,ageof subjects)design (controlled)planneddates (startandcompletion.)

1.12 informationoncomparatordevice

1.13evidence that theclinical investigatorand sitearecapableof conductionthe investigation

The Organisationfor Professionals inRegulatory Affairs

Documents - Annex XV. Chapter II

1.Application form

1.14startdateandduration 1.15notifiedbody (ifalready involved in thedevice) 1.16confirmationthat thesponsor isaware the MSmaycontacttheethicscommittees 1.17signedstatementby legalmanufacturerthatdeviceconformstogeneralsafetyand performancerequirementsapart from the aspectscoveredby the clinical investigationandevery precautionhasbeen taken toprotect thehealthandsafetyof the subject.

2. Investigator’sBrochure

Changesto IBneed tobe provided to the investigators

2.1and2.2.The Ibdescribes thedevice, itsclassification, instructions, informationtobe includedon the label

2.3preclinicalevaluation

2.4existingclinicaldata

2.5benefitriskand riskmanagement

2.6 informationondevices that includemedicinalproductsetc.

2.7a listdetailing the fulfilmentofGSPRasperannex1.

2.8detaileddescriptionof clinicalproceduresexplainingdeviation fromnormalclinicalpractice

The Organisationfor Professionals inRegulatory Affairs