Assess and designate Notified Bodies - TOPRA

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20 Role of the Manufacturer • The manufacturer has total responsibility for ensuring product complies with Medical Device Directives before CE-marking it <strong>and</strong> placing it on the market • The manufacturer signs a Declaration of Conformity when: – Satisfied that the product meets Directives’ requirements – Necessary conformity assessments are complete 20
Manufacturer: Product to CE mark Confirm the product is a medical device Establish the classification Choose conformity assessment route Prepare Quality Management System Technical Documentation Draft Declaration of Conformity Conformity assessment Receive Certificate Sign Declaration of Conformity Apply CE Mark 21
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: Conformity Assessment: Steps to CE-
Page 23 and 24: 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 43 and 44: Manufacturer: Product to CE mark Co
Page 45 and 46: We have covered • The roles and i
Page 47: QUESTIONS

Assess and designate Notified Bodies - TOPRA

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