Module 16 2024

10/17/2024

Are there any further Guidance Documents?

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Description automatically generated

Until the end of 2022, things were pretty

quiet regarding MDCG guidance

documents on post-market surveillance

(PMS).

However, as of today, the MDCG has

actively published guidances to assist

medical device manufacturers

implementing a compliant Post-Market

Surveillance Process.

Source: https://health.ec.europa.eu/medical-devices-sector/new-regulations/guidance-mdcg-endorsed-documents-and-other-guidance_en#sec16

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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Is there any other Guidance? ISO/TR 20416:2020

The Organisation for Professionals in Regulatory Affairs

10/17/2024 Confidential

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