Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

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

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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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