|Theme||Clinical Evaluation – Equivalence|
|Products concerned||MD and Products of Annex XVI|
|Regulatory references||MDR (EU) 2017/745
Annex XIV PART A (3)
|Documents mentioned||MEDDEV 2.7/1 rev. 4 (2016) : Clinical evaluation: Guide for manufacturers and notified bodies|
EN – This guide focuses on the demonstration of equivalence in the framework of the clinical evaluation of Medical Devices.
This notion, absent from the MD and AIMD Directives, but present in MEDDEV 2.7/1 rev. 4, is now an integral part of the RDM.
This guide highlights the differences between the RDM and MEDDEV 2.7/1 rev. 4 and defines the process for demonstrating equivalence. A table of equivalence is appended to the document, proposing a method for demonstrating equivalence.