Module 15 Presentations

10/04/2024

Technical equivalence

MDR vs MDD (MEDDEV 2.7/1 rev 4)

Source: MDCG 2020-5

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

15

Technical equivalence

Actual

Equivalent

?

=

No clinically significant difference in the safety and clinical performance of the device?

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

16

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