Module 15 2022

19/05/2022

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 5

19

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 5

20

10