EFDA EFDAEFDA/GDL/092 Version No: 002
EFDA/GDL/092 Version No: 002 is the official EFDA identifier for “Guideline for Marketing Authorization of Low-Risk Medical Devices (EFDA/GDL/092)”. EFDA/GDL/092 Version No: 002 is the official identifier EFDA uses for this instrument.
- Instrument
- EFDA
- Full name
- EFDA/GDL/092 Version No: 002
- Category
- Registration
- Authority source
- English
- Readable HTML
- 22 articles · 1 language version
- Published
- 2026-06-20
- Effective
- 2026-06-30
Open a language version
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 Marketing Authorization of Low-Risk Medical Devices (EFDA/GDL/092)
The abridged route for low-risk devices: what a low-risk application must contain and how it is handled, with the checklists and forms the Authority issues for it. Version 002, approved 20.06.2026, effective 30.06.2026, first issued 2022. Its contents leaders with ellipsis characters rather than periods and its contents numbering is one ahead of its body: the contents reads 1 INTRODUCTION / 2 OBJECTIVE / 3 SCOPE while the body prints a bare "INTRODUCTION" and then "1 OBJECTIVE" and "2 SCOPE". The extract labels each block with the number the body prints and leaves the disagreement standing.
EFDA/GDL/092 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.