Assess and designate Notified Bodies - TOPRA

More documents

Recommendations

Info

NBOG Documents • Designating Authorities Handbook • Best Practice Guides – Change of Notified Body – Guidance on Design-Dossier Examination and Report Content – Role of Notified Bodies in the Medical Device Vigilance System – Guideline for Designating Authorities to Define the Notification Scope of a Notified Body Conducting Medical Devices Assessment – Guidance on Notified Body‘s Tasks of Technical Documentation Assessment on a Representative Basis – Guidance for Notified Bodies auditing suppliers to medical device manufacturers – Guidance on Audit Report Content – Certificates issued by Notified Bodies with reference to Council Directives 93/42/EEC, 98/79/EC, and 90/385/EEC • Checklists – Checklist for audit of Notified Body’s review of Clinical Data/Clinical Evaluation • Forms – Notification form – Directive 93/42/EEC – Notification form – Directive 90/385/EEC – Notification form – Directive 98/79/EC – Certificate Notification to the Commission and other Member States
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 • Surveillance continues............ Apply CE Mark 43
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 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: 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

Create successful ePaper yourself

Delete template?

Save as template?