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Difference between MDR Annex IX and Annex XI for Class IIa Technical File Review

Anonymous · Published December 08, 2025 · 1 comment
In the context of MDR Class IIa technical file review (certification), what is the difference between Annex IX and Annex XI? Specifically, are there significant advantages to choosing Annex XI over Annex IX, or is it simply an alternative conformity assessment route?

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Anonymous 7 months ago
Please specify if you are referring to a specific type of device or software, as this may affect the recommended conformity assessment route.
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Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
For Annex XI, you also need a type examination according to Annex X. This basically means that the notified body will fully test the product themselves, and you use Annex XI to prove that all future products will be identical to the one tested. In contrast, Annex IX is more commonly used for SaMD and involves a review of your quality management system and technical documentation rather than hands-on product testing of a specific sample.

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Anonymous ·
Annex XI is generally considered an alternative route, but it's rarely chosen for software as a medical device (SaMD). The main reason is that it involves more direct product testing by the notified body, which is less practical for software products compared to the quality system and documentation review under Annex IX.

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Difference between Annex IX and Annex XI for MDR Class IIa Technical File Review

Anonymous · 1 comment
6 months ago
Hello, In terms of MDR Class IIa Technical File review (certification), what is the difference between Annex IX and Annex XI?
Accepted 1 answer

Annex IX and Annex XI are two different conformity assessment routes under the MDR for Class IIa medical devices. • Annex IX is the full Quality Manag

MDR Declaration of Conformity

MDR Declaration of Conformity

Sven Piechottka

updated about 2 years ago
A

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

Anonymous · 1 comment
5 months ago
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 u
Accepted 1 answer

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

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