EFDA EFDAEFDA/GDL/046 Version No: 005
EFDA/GDL/046 Version No: 005 is the official EFDA identifier for “General Guidelines for Marketing Authorization of Medical Devices (EFDA/GDL/046)”. EFDA/GDL/046 Version No: 005 is the official identifier EFDA uses for this instrument.
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- EFDA
- Full name
- EFDA/GDL/046 Version No: 005
- Category
- Registration
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- 50 articles · 1 language version
- Published
- 2026-06-05
- Effective
- 2026-06-25
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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.
General Guidelines for Marketing Authorization of Medical Devices (EFDA/GDL/046)
The master marketing-authorization guideline: the application route, the dossier the Authority expects, how the application is screened and assessed, the decision and the certificate, with the annexes that carry the templates. Version 005, approved 05.06.2026 with an effective date of 25.06.2026 and a first issue date of 2022; the Document History table runs 001 (new guideline, 2022) through 005, so this version supersedes the third-edition guideline the earlier batch triage pointed at. The extract keeps 55 body sections located from the document's own contents, including the annexes (`ANNEX I` to `ANNEX V`, one of which is the application letter template), and the block labels are the numbers the body headings print — the contents writes "Annex III:- Application letter template" with a colon and a dash, which is the source's spelling and is not normalised.
EFDA/GDL/046 Version No: 005 is the official identifier EFDA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.