Module 18 2021

2/9/2021

What does “equivalent” mean? Clinical Technical

Biological

• Same materials in contact with same human tissues

• Same clinical condition • Same intended purpose • Same site in the body

• Similar design • Similar conditions of use • Similar specifications and properties • Similar principles of operation and performance requirements

• Similar population • Similar expected performances

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MDCG 2020-5 Provides Equivalence Information under MDR

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What is suitable for Article 61 (10)?

It is not a route for devices where there is a lack of clinical data, it is for devices where clinical data is not appropriate. Devices qualifying under Article 61 (10) do not make clinical claims.

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