EFDA EFDAEFDA/GDL/097 Version No: 002
EFDA/GDL/097 Version No: 002 is the official EFDA identifier for “Guideline for Registration Requirements of Medical Devices other than In Vitro Diagnostic Devices (EFDA/GDL/097)”. EFDA/GDL/097 Version No: 002 is the official identifier EFDA uses for this instrument.
- Instrument
- EFDA
- Full name
- EFDA/GDL/097 Version No: 002
- Category
- Registration
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- English
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- 86 articles · 1 language version
- Published
- 2026-06-15
- Effective
- 2026-06-30
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Guideline for Registration Requirements of Medical Devices other than In Vitro Diagnostic Devices (EFDA/GDL/097)
The registration-requirements guideline for devices other than IVDs: what the technical file must contain, section by section. Version 002, approved 15.06.2026, effective 30.06.2026, first issued 2022. It is the longest of the eight guidelines and the one whose own numbering is least tidy: its contents breaks across a page boundary (the extract's contents reader had to accept an eight-line blank run inside the contents itself), it prints chapters as an unnumbered level (`CHAPTER ONE` … `CHAPTER FIVE`, plus `6A`, `6B` and `ANNEX-I`), and its body reaches `4.2.3` with no `4.2` and restarts at `1.1`/`2.1` under section 5. All of that is reproduced as printed; the extract holds 87 located sections and reconciles nothing.
EFDA/GDL/097 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.