Assess and designate Notified Bodies - TOPRA

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Conformity <strong>Assess</strong>ment: Risk Based Classes 18 classification rules (Annex IX) low Risk high sterile or with a measuring function S17
Conformity <strong>Assess</strong>ment: Criteria for Risk Classification • invasive / non-invasive • surgically invasive / non-surgically invasive • implantable / non-implantable • active / non-active • short-term / long-term use • application on critical organs: central nervous system, central blood circulation system intended use
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: Conformity Assessment Routes • If
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 and 26: Use of Standards 2 5 • Manufactur
Page 27 and 28: Relationship between Standard and D
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

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