Medical device standards update: July 2026

1. image 1 same image in previous MedDev updates

Introduction

This edition of our regular column updates the progress of applicable standards to July 2026.

Since the previous update, several important developments have occurred across both the EU harmonised standards lists and the US Food and Drug Administration (FDA) recognised consensus standards database. While the publication of new EU harmonised standards had previously slowed due to legal challenges surrounding access to harmonised standards, recent months have seen renewed activity, including the addition of several updated ISO and IEC standards.

Several previously listed standards have also been withdrawn and replaced by updated editions. As regulatory bodies increasingly recognise newer versions, manufacturers are expected to transition to the latest editions to maintain alignment with current state-of-the-art requirements.

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