Module 15 Presentations

10/04/2024

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 you cannot use non ancillary medicinal device to support ancillary medicinal device, and vice versa, e.g., non-drug eluting stent vs drug eluting stent

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

23

Biological equivalence

Four sizes of Aquacel AG+ Extra Silver Hydrofiber Wound Dressings

Same materials, but do they have the similar release characteristics?

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

24