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EQUIVALENCE clinical- same condition, purpose/body site/critical performance- similar population technical- similar conditions of use/ specifications/design/ deployment/ principles operation biological- same materials- same tissue contactSafeguarding Public Health<strong>MHRA</strong>Slide 162010©
APPRAISAL suitability of data type of publication (case reports, random experience etc) relative weighting demonstration equivalence completeness of data contribution results to demonstration performance, safetySafeguarding Public Health<strong>MHRA</strong>Slide 172010©
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 and 10: CLINICAL DATA“……..as a genera
Page 11 and 12: ESSENTIALREQUIREMENTS“…..demons
Page 13 and 14: GHTF DOCUMENTS clinical evidence: d
Page 15: SOURCES OF DATA literature searchin
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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