Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Conformity Assessment Procedures

 Class C ● EC Declaration of Conformity (Annex IX) : Quality Assurance with parts of Chapter 2 – Sampled by Notified Body according to plan based on the generic device groups ● OR : EC Type Examination (Annex X) coupled to EC Declaration of Conformity (Annex XI) - Production Quality Assurance

 Assessment made by Notified Body

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Conformity Assessment Procedures – Class C

Notified Body

Manufacturer’s choice

Full QA (Annex IX) with assessment of technical documentation (Parts of Chapter 2)

EC Type Examination (Annex X)

Production QA (Annex XI)

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