Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

MedDev 2.7/1 Rev 4 65 pages – 12 sections, 12 Appendices Addresses processes, literature search methods, equivalence, requirements for competence, factors affecting scientific validity, report content, requirements for Notified Body review and reports, etc

The Holy Document of Clinical Evaluations! Specific to the Directives but….

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The Organisation for Professionals in Regulatory Affairs

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MDCG 2020-6: “Sufficient clinical evidence” for legacy devices

Sections of MedDev 2.7/1 rev 4 which are still relevant under the MDR

The Organisation for Professionals in Regulatory Affairs

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