Module 3 Presentations

07/05/2024

In a nutshell: Documents

Summary • Regulatory and non-regulatory (technical) specifications have to be available as separate documents • The level of detail for regulatory specifications should be “appropriate” – As much as necessary, as less as possible. • If a drawing is needed: Use schematic drawing – not the technical drawing including all tolerances

The Organisation for Professionals in Regulatory Affairs

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Example: Pre-filled syringe Is this a pure (drug) container? Specifics on Drug-Device combinations

MDCG 2022 – 5 Guidance on borderline between medical devices and medicinal products under Regulation (EU) 2017/745 on medical devices

The Organisation for Professionals in Regulatory Affairs

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