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Stricter 'Equivalency' Requirements On The Cards For EU Device Clinical Evaluations

This article was originally published in SRA

Executive Summary

A key working group at the European Commission has approved major changes to the current guideline on clinical evaluation of medical devices (MEDDEV 2.7/1, Rev 3)1, including stricter requirements for demonstrating equivalency between a device under evaluation and an approved product, says Françoise Schlemmer, director of the EU association of medtech notified bodies (TEAM-NB).