Module 15 Presentations

10/04/2024

Summary

So, are they equivalent?

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The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

41

Relevant Guidance

• MDCG 2023-6 Guidance on demonstration of equivalence for Annex XVI products - A guide for manufacturers and notified bodies, December 2023 • MDCG 2023-7 Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of access’ to data needed to justify claims of equivalence, December 2023 • MDCG 2020-6 Guidance on sufficient clinical evidence for legacy devices, April 2020 • MDCG 2020-5 Guidance on clinical evaluation – Equivalence, April 2020

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

42