Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Conformity Assessment Procedures

 Class D ● EC Declaration of Conformity (Annex IX) : Quality Assurance – Including assessment of technical documentation (complete Chapter 2) ● OR : EC Type Examination (Annex X) coupled to EC Declaration of Conformity (Annex XI) - Production Quality Assurance ● No sampling, each device Technical Documentation reviewed and approved by NB ● Batch verification ● Verification of design by Reference Lab

The Organisation for Professionals in Regulatory Affairs

9

Conformity Assessment Procedures – Class D

Notified Body

Manufacturer’s choice

QA (Annex IX) with assessment of technical documentation

EC Type Examination (Annex X)

Production QA (Annex XI)

(Chapter 2 Complete)

of 21

The Organisation for Professionals in Regulatory Affairs

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