Module 18 - Drug Device Combinations and Other Technologies

12/7/2023

Equivalence: Reminder

Note: Access to Data Requirements under MDR!

 

Y

Clinical data sufficient ?

Y

Equivalence demonstrated ?

Subject device

N



Claimed equivalent

N

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What does “equivalent” mean? Clinical • Same clinical condition • Same intended purpose • Same site in the body • Similar design • Similar conditions of use • Similar specifications and properties • Similar principles of Technical

Biological

• Same materials in contact with same human tissues

operation and performance requirements

• Similar population • Similar expected performances

MDCG 2020-5 Provides Equivalence Information under MDR

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