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

Anonymous · Published December 29, 2025 · 1 comment
Hello,
In terms of MDR Class IIa Technical File review (certification), what is the difference between Annex IX and Annex XI?

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Anonymous 5 months ago
Please clarify if you are asking about conformity assessment routes or about documentation requirements.
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1 Answer

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
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 Management System (QMS) route. Here, your Notified Body will audit your entire QMS and review the technical documentation for at least one representative device per category. This is often chosen if you have a mature QMS and plan to certify multiple devices.
  • Annex XI (Part A) is the Production Quality Assurance route. With this path, the Notified Body focuses on your production process and does not review the full QMS. You submit technical documentation for assessment, but the QMS scope is narrower, mainly around manufacturing and final inspection.
In summary: Annex IX is broader and covers the whole QMS and product design, while Annex XI is more limited to production and may be suitable if you only want certification for a specific device or group.

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A

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

Anonymous · 1 comment
7 months ago
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 An
Accepted 2 answers

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 themselve

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updated about 2 years ago
A

Is it necessary to have technical documentation ready before certifying the QMS under MDR for a class IIa device?

Anonymous · 2 comments
12 months ago
We are preparing to certify our Quality Management System (QMS) but do not yet have all of the technical documentation for our medical device completed. According to MDR 2017/745 (Annex IX, Chapter 1,
Accepted 4 answers

Certification to ISO 13485 is independent from being a manufacturer under MDR Annex IX. Many certification bodies are not Notified Bodies for MDR, so

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