Module 18 2021

2/9/2021

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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Copyright © 2020 BSI. All rights reserved

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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

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Copyright © 2020 BSI. All rights reserved

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