Medicines Authority GL-MDF19GL-MDF19/02
GL-MDF19/02 is the official MMA identifier for “Guidance for Application Forms MT-MDF12 and MT-MDF13 for a Derogation from the Conformity Assessment Procedures of Medical Devices”. GL-MDF19/02 is the official identifier MMA uses for this instrument.
- Instrument
- GL-MDF19
- Full name
- GL-MDF19/02
- Category
- Registration
- Authority source
- English
- Readable HTML
- 9 articles · 1 language version
- Published
- February 2026
- Effective
- —
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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.
Guidance for Application Forms MT-MDF12 and MT-MDF13 for a Derogation from the Conformity Assessment Procedures of Medical Devices
Medicines Authority guidance note GL-MDF19/02, Ref No. GL-MDF19/02, February 2026, on application forms MT-MDF12 and MT-MDF13 for a derogation from the conformity assessment procedures of medical devices. This is the national surface for the derogation route by which a device may be placed in service without the applicable conformity assessment procedure having been carried out, and the note states which form applies to which case. The note carries a reference list of the other GL-MDF and GL-MDS notes, which is retained in the extract rather than stripped as page furniture.
GL-MDF19/02 is the official identifier MMA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.