Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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)

of 21

The Organisation for Professionals in Regulatory Affairs

13

Art. 50 Scrutiny procedure

 Class D products

 NB notifies the CA of certificates it has granted.

 CA may apply further procedures in ● Art. 40 Monitoring and re-assessment of NBs ● Art. 41 Review of NB assessment of Tech Doc and of Performance Evaluation ● Art. 42 Changes to designations and notifications ● Art. 43 Challenge to the competence of NBs ● Art. 89, 90 and 92 related to dealing with devices presenting an unacceptable risk to health and safety and non-compliant products

 MDCG may request scientific advice from experts

of 21

The Organisation for Professionals in Regulatory Affairs

14