Do IVDR Annex IX Chapter II certificates apply to Class C devices?

Anonymous · Published February 05, 2026 · 1 comment

Our company received an EU Quality Management System Certificate (IVDR) for Annex IX Chapters I and III. We have a Class C device (not for self-testing, near patient testing, or companion diagnostic use). I am wondering if we should also expect an EU Technical Documentation Assessment certificate (IVDR) for Annex IX Chapter II. Is this certificate applicable to our device class?

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Anonymous 4 months ago

Have you checked IVDR Article 48 for details about the requirements for different device classes?

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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory · 5 months ago

You won’t get a product-specific (Annex IX Chapter II) certificate for a Class C device. Those certificates are only issued for Class D devices.

For Class C devices, the technical documentation is assessed as a representative sample ("sampling") rather than as a mandatory individual assessment under Chapter II. See IVDR Article 48, points 3 and 7 for reference.

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