Module 19: Regulation of In Vitro Diagnostic Medical Devices

13/04/2023

The Organisation for Professionals in Regulatory Affairs

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The Role of the Notified Body Assessment of Technical Documentation

 Product changes have to be approved by the NB ● Where such changes could affect the safety and performance or the prescribed conditions of use  Special cases:  Class D ● Verification of performance by European Reference Laboratory ● Includes testing by ERL  Self-testing devices  Companion Diagnostics: EMA involvement

The Organisation for Professionals in Regulatory Affairs

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