The Medical Devices Introductory Course 2020

IVDD Conformity Routes – “Annex II A IVD

Main route used by manufacturers

Annex II A Device

Annex IV Quality Assurance (ISO 13485) Audit by NB

Annex V EC Type Examination by NB

Product Design Dossier examination (Annex IV, Sec 4) by NB

Annex VII Product Quality Assurance (ISO 13485) Audit by NB

Batch or product verification (Annex IV, sec 6) by NB

Batch or product verification (Annex VII, sec 5) by NB

CE Mark

CE Mark

The Organisation for Professionals in Regulatory Affairs

IVDR Conformity Assessment Routes

The Organisation for Professionals in Regulatory Affairs

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