Module 15 Presentations

10/04/2024

Biological equivalence

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

19

Biological equivalence

MDR Annex XIV Part A section 3 • Biological: • the device uses the same materials or substances in contact with the same human tissues or body fluids • for a similar kind and duration of contact and similar release characteristics of substances, including degradation products and leachables;

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

20