Module 15 2022

19/05/2022

Key concepts to equivalence

The Frankenstein approach is not acceptable • MDR Annex XIV Part A section 3

[…] a device […] […] the device.

MDCG 2020-5 clarifies “each device shall be equivalent to the device under evaluation in all the listed technical, biological and clinical characteristic”*

•

*Limited exception for device ‘systems’, but from same manufacturer

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

11

Technical equivalence

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

12

6