Assess and designate Notified Bodies - TOPRA

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Conformity <strong>Assess</strong>ment: Examples for Risk Classification • Class I – wheel chairs, patient beds, non-invasive electrodes • Class I* – sterile wound dressings, thermometer • Class IIa – ultrasound diagnostic device, respiration tubes, blood pressure monitoring devices, products for transition of blood • Class IIb – Lithotripthers, ablation devices, ventilators • Class III – prosthetic heart valves, neurologic catheters, artificial joints, breast implants, combination products
Conformity <strong>Assess</strong>ment Procedures manufacturer Annex VII notified body sterile or with a measuring function: Annex V Annex VII + Annex IV, V or VI Annex II without design examination or Ann. III + Ann. IV, V or VI Ann. II with design examination Ann. III + Ann. IV or V
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: Conformity Assessment: Criteria for
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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