Module 15 Presentations

10/04/2024

Key concepts to equivalence

MDR Annex XIV Part A section 3 : A clinical evaluation may be based on clinical data relating to a device for which equivalence to the device in question can be demonstrated. The following technical, biological and clinical characteristics shall be taken into consideration for the demonstration of equivalence:

— Technical: […] — Biological: […] — Clinical: […]

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

7

Key concepts to equivalence

• The three characteristics of equivalence: • Technical (e.g., design, use, performance) – SIMILAR • Biological (e.g., materials, degradation and release) - SAME • Clinical (e.g., clinical condition, population, site in the body) – SAME/SIMILAR • The ‘General principle’ of equivalence is unchanged since 2003 HOWEVER: • There is increased granularity within the sub-characteristics, and a need to document and justify with evidence • There is increased scrutiny by the NBs and Designating Authorities • Notified Bodies lean towards the same, rather than similar

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

8