Module 15 Presentations

10/04/2024

Biological 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

21

Biological equivalence

Does it really have to be the same material? •

Does “ Same materials or substances” = IDENTICAL raw material? • It may be simple for some device – e.g., implants to known standards • It will be challenging for a lot of devices – e.g., polymeric skin-contacting components • ISO 10993-18 could be used to support biological equivalence? Any differences will need to be disclosed and justified with evidence why they are the ‘same’ • Does “ similar release characteristics of substances” = same processing/design/use environment? • No, only needs to be similar ) • ISO 10993-17 and -18 can be used to characterize the final device

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

22