Module 15 2022

19/05/2022

Biological equivalence

Does it really have to be same material? •

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

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

21

Biological equivalence

Specific biological considerations: • Devices composed of substances or combinations of substances e.g. fat-binding medical devices (sliming aids) • Same materials or substances – MDCG 2020-5 confirms substances must be the same • Devices with an ancillary medicinal substance e.g. antibiotic bone cement, drug eluting stents • Same materials or substances – MDCG 2020-5 confirms that cannot use non-ancillary medicinal device to support ancillary medicinal device, and vice versa, e.g. drug non drug eluting stent vs drug eluting stent

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

22

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