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CLINICAL DATA“…..safety and/or the performance informationgenerated from the use of the device sourcedfrom:- clinical investigations- other studies in the scientific literature forwhich equivalence can be demonstrated- published and/or unpublished reports onother clinical experience of device orequivalent…….”MDD: article 1Safeguarding Public Health<strong>MHRA</strong>Slide 102010©
ESSENTIALREQUIREMENTS“…..demonstration of conformity with the essentialrequirements must include a clinical evaluation inaccordance with Annex X…….”MDD: annex I:6aSafeguarding Public Health<strong>MHRA</strong>Slide 112010©
Page 1 and 2: Safeguarding public healthCLINICAL
Page 3 and 4: NHS NEGLIGANCE2009/10£827,367,000S
Page 5 and 6: NUMBERS/CLAIM VALUESafeguarding Pub
Page 7 and 8: EU REGULATORY SYSTEMarticle 20inves
Page 9: CLINICAL DATA“……..as a genera
Page 13 and 14: GHTF DOCUMENTS clinical evidence: d
Page 15 and 16: SOURCES OF DATA literature searchin
Page 17 and 18: APPRAISAL suitability of data type
Page 19 and 20: STAGES EVALUATIONidentify clinical
Page 21 and 22: ? EQUIVALENCE atrial appendage plug
Page 23 and 24: CLINICAL INVESTIGATION when underta
Page 25 and 26: ISSUES pre-market testing inadequat
Page 27 and 28: ENDPOINTS clinical investigation re
Page 29 and 30: PMCFpost-market clinical follow-up
Page 31 and 32: SUMMARY the requirements Directives

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