HSA GL-07GL-07
GL-07 is the official HSA identifier for “Guidelines on the Risk Classification of Software as a Medical Device and Clinical Decision Support Software”. GL-07 is the official identifier HSA uses for this instrument.
- Instrument
- GL-07
- Full name
- GL-07
- Category
- Software/SaMD
- Authority source
- English
- Readable HTML
- 4 articles · 1 language version
- Published
- July 2025
- 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.
Guidelines on the Risk Classification of Software as a Medical Device and Clinical Decision Support Software
HSA GL-07 Revision 2 (July 2025) applying the IMDRF risk categorization framework to SaMD and setting out when clinical decision support software is regulated. Exact PDF from the official guidance-documents collection. Ingested as four banner sections (Introduction, Classification, Clinical Decision Support Software, References) with the risk-classification matrix kept as tabular text.
GL-07 is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.