Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Conformity Assessment Procedures

 Class A ● Declaration of Conformity (Art. 17) ● Product : Technical Documentation (Annexes II and III) ● Incident reporting and post-production review ● Quality system risk management and other general requirements including the General Safety and Performance Requirements ● Quality Management System (details given) ● No notified body certification unless for sterile products

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The Organisation for Professionals in Regulatory Affairs

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Conformity Assessment Procedures – Class A

Sterile

EC Declaration of Conformity

Not sterile

Sterility (Annex IX or XI)

Notified Body

The Organisation for Professionals in Regulatory Affairs

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