Module 15 2022

19/05/2022

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 5

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 • ‘General principle’ of equivalence unchanged since 2003 HOWEVER: • Increased granularity within sub-characteristics – and need to document and justify with evidence • Increased scrutiny by Notified Bodies and Designating Authorities • Notified Bodies lean towards the same, rather than similar

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

8

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