Module 15 Presentations

10/04/2024

Non-implantable and non-class III devices

MDCG 2020-6, Section 4(e): For devices other than implantable or Class III devices EQUIVALENCY can be claimed against: • Devices certified with respect to the Directives MDD/AIMDD • Devices that are not CE-marked providing • The manufacturer can demonstrate sufficient access to the technical/clinical data • The clinical investigations were conducted in accordance with international guidelines • The clinical data meets the requirements of the MDR and is transferrable to the European population

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

35

How to present an equivalence assessment

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 7

36