Assess and designate Notified Bodies - TOPRA

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Example recommendation http://www.team-nb.org/Documents/R2_5_1-6_rev4.pdf
NB-MED/2.5.1/Rec6 Renewal of EC Design-Examination and Type-Examination Certificates • The purpose of this Recommendation is to describe the procedure for renewal of EC Design-Examination Certificates or Type-Examination Certificates, so as to avoid the following extremes: – automatic renewal – repeating the complete previous product assessment without due recognition of previous Notified Body approvals (both original and for substantial changes). • Contents – Introduction – Scope – Purpose – Renewal Procedure – Rationale and History Sheet
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 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: NB Recommendations • http://www.t
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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