HSA 3D-Printed3D-Printed
3D-Printed is the official HSA identifier for “Regulatory Guidelines for 3D-Printed Medical Devices”. 3D-Printed is the official identifier HSA uses for this instrument.
- Instrument
- 3D-Printed
- Full name
- 3D-Printed
- Category
- Registration
- Authority source
- English
- Readable HTML
- 9 articles · 1 language version
- Published
- July 2021
- Effective
- —
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.
Regulatory Guidelines for 3D-Printed Medical Devices
HSA guideline (July 2021, stating the current position as of 01 August 2022 in its conclusion) on additive-manufactured devices: categorisation of mass-produced versus custom-made and patient-matched devices with the in-line decision flowchart; regulatory controls by category (product registration including the Annex 2 for GN-17 list of configurations, the Table A basic dossier considerations for all 3D-printed devices, and dealer licensing with post-market obligations); plus IMDRF references. Exact PDF from the official guidance-documents collection. Ingested as sec-1 through sec-4 with annex-references, the Table A considerations kept as tabular text with repeated table headers, and sub-sections 3.1–3.4 as anchored blocks.
3D-Printed is the official identifier HSA uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.