Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

Conformity Assessment Procedures

 Class B ● EC Declaration of Conformity (Annex IX) : Full Quality Assurance ● Sample of product prior to issue of QMS Certificate – At least one device per category of devices covered by application ● Samples of technical documentation during certification period  Assessment made by Notified Body

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The Organisation for Professionals in Regulatory Affairs

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Conformity Assessment Procedures – Class B

Notified Body

Manufacturer

Annex IX (Quality Assurance) Chapters 1 and 3

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