Module 15 2022

19/05/2022

Specific requirements for equivalence: Non-implantable and non-Class III devices

The Organisation for Professionals in Regulatory Affairs

Module 15 Lecture 5

33

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 5

34

17