Essentials of European Medical Device Regulatory Affairs - October 2019

Conformity Assessment Procedures: Annex IX to XI

Annex X • Based on Type Examination • Assessment of the technical documentation • Assessment and testing of device – representative sample – Notified Body tests the device (or manufacturer) – Type examination certificate • Any changes to the device design require approval • Additional assessment processes for some devices (annex IX section 5)

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Conformity Assessment Procedures: Annex IX to XI

Annex XI • Product Conformity Verification • Linked to type examination • Follow Part A or Part B: • Part A: Production Quality Assurance – QMS (excluding design processes) – Technical documentation • Part B: Product Verification – NB Examines and tests every manufactured device – documented manufacture process – PMS – EU product verification certificate

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