Assess and designate Notified Bodies - TOPRA

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Horizontal Harmonised Standards apply across device classes EN ISO 13485:2003 EN ISO 14971:2009 EN ISO 10993 Medical devices - Quality management systems - Requirements for regulatory purposes Medical devices - Application of risk management to medical devices various parts relating to Biological evaluation of medical devices (biocompatibility, toxicity…) EN ISO 14155-1:2009 Clinical investigation of medical devices for human subjects - Part 1: General requirements EN ISO 14155-2:2009 Clinical investigation of medical devices for human subjects - Part 2: Clinical investigation plans EN 980:2008 EN 1041:2008 EN ISO 22442-1:2007 Symbols for use in the labelling of medical devices Information supplied by the manufacturer of medical devices Various parts relating to medical devices utilizing animal tissues and their derivatives 26
Relationship between Standard and Directive BS EN ISO 22442-1:2007 relating to medical devices utilizing animal tissues and their derivatives
Page 2: Notified Bodies Neil Adams B.Sc. Ph
Page 5 and 6: In this presentation we will cover
Page 7 and 8: Conformity Assessment by Notified B
Page 9 and 10: 9 Role of the Member States • “
Page 11 and 12: Conformity Assessment Routes • If
Page 13 and 14: Conformity Assessment: Criteria for
Page 15 and 16: Conformity Assessment Procedures ma
Page 17 and 18: Conformity Assessment: Type Examina
Page 19 and 20: Conformity Assessment: Steps to CE-
Page 21 and 22: Manufacturer: Product to CE mark Co
Page 25: Use of Standards 2 5 • Manufactur
Page 29 and 30: Vertical Harmonised Standards Verti
Page 31 and 32: Conformity assessment Notified Body
Page 33 and 34: Medical Devices Expert Group (MDEG)
Page 35 and 36: MEDDEVs 2.1 Scope, field of applica
Page 37 and 38: NB Recommendations • http://www.t
Page 39 and 40: NB-MED/2.5.1/Rec6 Renewal of EC Des
Page 41 and 42: NBOG Activities • Training for De
Page 45 and 46: We have covered • The roles and i
Page 47: QUESTIONS

Assess and designate Notified Bodies - TOPRA

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