Module 19: Regulation of In Vitro Diagnostic Medical Devices

18/04/2023

Regulatory Framework

Innovation office/ General Advice

Device development

PS approval

Post Market Surveillance Compliance Vigilance

Where does the NCA fit in?

Performance Evaluation

CE Mark

Notified Bodies

Harmonised Standards and Common Specifications

The Organisation for Professionals in Regulatory Affairs

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What’s the difference between a regulation and a directive?

Europa – the official website of the EU – explains the difference. A regulation is a binding legislative act. It must be applied in its entirety across the EU. A directive is a legislative act that sets out a goal that all EU countries must achieve. However, it is up to the individual countries to devise their own laws on how to reach these goals.

https://europa.eu/european-union/eu-law/legal-acts_en

The Organisation for Professionals in Regulatory Affairs

Setting the Scene – EU Focus

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