Member States publish their 2025 monitoring reports on notified bodies under MDR and IVDR

The European Commission published the Member State summaries of their 2025 annual reports on the monitoring and on-site assessment of notified bodies on 20 July 2026. It is a quiet release with an uncomfortable subject: how well the bodies that grant your certificate are themselves being supervised.

Designation is not a one-off event. The authority that designated a body has to keep testing it, through annual surveillance, on-site assessment, and witnessed audits where assessors sit in while the notified body audits a real manufacturer. These summaries are each Member State’s account of what that supervision turned up across 2025. Where a body was found short, that is where it shows.

Most manufacturers pick a notified body on capacity and price, which is understandable when the queue is the binding constraint. The supervisory record is the third variable, and it is the one that determines whether the certificate holds up. If your CE marking depends on a body, how its designating authority views its scope and resourcing is part of your risk file whether or not you have read it. Our notified body directory lists who is designated for what, which is the quickest way to line a body up against the report covering it.

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