Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Conformity Assessment Procedures

 Devices for self-testing and near-patient testing ● Specific requirements apply – Demonstrate usability – Show studies – ...  Companion Diagnostics ● Involvement of European Medicines Agency (EMA)

 Both have Techncal Documentation reviewed for each device before certificate issued

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Annexes

 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

 Note: EC Verification (Annex VI of IVDD) does not exist anymore

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