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Is it necessary to include device classification and intended use in every section of DHF and TD documentation?

Anonymous · Published December 21, 2025 · 1 comment
Is it required to always include sections with device classification, device description, intended use, contraindications, and indications at the beginning of every document in the Design History File (DHF) and Technical Documentation (TD)?
I would like to avoid unnecessary duplication, but I want to ensure compliance with regulatory requirements. What is the best practice?

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Anonymous 6 months ago
Are you referring to both MDR and FDA requirements, or just one?
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3 Answers

Accepted answer Dr. Oliver Eidel · Founder & CEO, OpenRegulatory ·
You don't need to include those sections in every document. Both the Technical Documentation and DHF can either contain or reference documents that demonstrate conformity. I prefer referencing so you avoid duplicating information, which can lead to inconsistencies.
Check the definitions in FDA CFR 820.3(e), 820.30(f), and MDR Annex II for more details. As long as the information is easily accessible and traceable, referencing is sufficient.

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Anonymous ·
Basically, no, you don't have to repeat it everywhere. But if you're sending out a single document for a specific purpose, it can be helpful to include it for clarity. We usually avoid repeating unless necessary.

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Anonymous ·
This is the first time I've heard of including several pages of device information at the start of every document. We don't do this in our documentation process.

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