EFDA EFDAEFDA/GDL/041 Version No: 002
EFDA/GDL/041 Version No: 002 is the official EFDA identifier for “Guideline for Classification of Medical Devices Other than IVD Medical Devices (EFDA/GDL/041)”. EFDA/GDL/041 Version No: 002 is the official identifier EFDA uses for this instrument.
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- EFDA
- Full name
- EFDA/GDL/041 Version No: 002
- Category
- Classification
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- 13 articles · 1 language version
- Published
- 2026-06-20
- Effective
- 2026-06-30
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Each version has stable article anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Guideline for Classification of Medical Devices Other than IVD Medical Devices (EFDA/GDL/041)
The classification guideline for devices other than IVDs: the four risk classes and the rules that assign a device to one. Version 002, approved 20.06.2026, effective 30.06.2026; version 001 was first issued in 2021. Two things about the copy are worth recording because they are the source's and are not repaired: the file name says "V1" while the document itself is Version 002 (the file name is the publisher's), and the file name also spells the Authority "EEDA" against the `EFDA` the document uses throughout. Its body headings are the one set a generic heading scan could not see at all, which is why this market's extracts are TOC-driven.
EFDA/GDL/041 Version No: 002 is the official identifier EFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.