Module 19 2021

24/05/2021

Art. 50 Mechanism for scrutiny of conformity assessment of Class D devices.

NB notifies the CA of certificates it has granted for all Class D devices.

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

The Organisation for Professionals in Regulatory Affairs

17

Annexes of Relevance

Annex IV EU Declaration of Conformity Annex IX Conformity Assessment based on a quality management system and on assessment of the technical documentation Annex X Conformity Assessment based on Type Examination Annex XI Conformity Assessment based on Production Quality Assurance Annex XII Certificates issued by a Notified Body

The Organisation for Professionals in Regulatory Affairs

18

9