文档介绍：EUROPEANCOMMISSION
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Howtoweight thecontribution of each data set 26
Analysisof the clinical data (Stage3) 27
. Generalconsiderations 27
Specific considerations 27
Wheredemonstrationofconformitybasedonclinicaldataisnotdeemedappropriate...2911.
Theclinicalevaluation report(CER,Stage4) 29
12. Theroleofthenotifiedbodyintheassessmentofclinicalevaluationreports 31
Appendices 32
A1. Demonstrationof equivalence 32
A2. Whenshouldadditionalclinical investigations be carriedout? 34
A3. Devicedescription -typical contents 35
A4. Sourcesof literature 36
A5. Literaturesearch and literature reviewprotocol,keyelements 37
. Backgroundtothe literature search and the literature review 38
. Objective 38
. Methods 39
A6. Appraisal ofclinical data- examples of studies thatlack
scientificvalidityfordemonstrationofadequateclinical performanceand/orclinicalsafety 3. 9
A7. Analysisoftheclinicaldata-compliancetospecificEssentialRequirements 41
. Conformityassessmentwithrequirementonsafety(MDDER1/AIMDDER1) 41
. Conformityassessmentwithrequirementonacceptablebenefit/riskprofile
(MDDER1 /AIMDD ER1) 42
. Conformityassessmentwithrequirementonperformance(MDDER3/AIMDDER2)....
Conformityassessmentwithrequirementonacceptabilityofundesirableside-effects (MDDER6 /AIMDD ER5) 47
A8. Devicesforunmetmedicalneeds-aspects toconsider 48
A9. Clinicalevaluationreport-proposedtableofcontents,examplesofcontents 49
A10. Proposedchecklistforthe release ofthe clinicalevaluationreport 54
A11. Informationon declarationsof interests 56
A12. Activitiesofnotified bodies 56
. Notifiedbodyassessmentofclinicalevaluationbyconformityassessmentroute 56
. Examinationofadesigndossier(;)orofatypeexaminationdossier(AnnexIII;
Annex 3) 57
. Evaluationaspartof quality systemrelated procedures 61
. N