MDCG MDCGMDCG 2018-1 Rev.4
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
MDCG 2018-1 Rev.4 is the official MDCG identifier for “Guidance on BASIC UDI-DI and changes to UDI-DI”. MDCG 2018-1 Rev.4 is the official identifier MDCG uses for this instrument.
- Instrument
- MDCG
- Full name
- MDCG 2018-1 Rev.4
- Category
- UDI
- Source publication
- English
- Readable HTML
- 1 language version
- Published
- —
- Effective
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Each version has stable passage anchors for direct citations and highlighting. The readable text is generated from an authority source and does not replace the legally controlling publication.
Guidance on BASIC UDI-DI and changes to UDI-DI
Complete 4-page nonbinding MDCG guidance, printed April 2021, expressly addressing both MDR and IVDR UDI systems. Preserves name/trade-name/model triggers, misidentification and traceability qualification, direct-marking/UDI-PI/reuse conditions and footnotes on colour/language. Page 4 expressly excludes reprocessed devices, systems/procedure packs, software, Annex XVI, parallel trade and own-brand labelling. Does not decide whether a specific REF/logo change is a new device or give general registration/stock/fee/transfer permission. Complete unchanged official PDF, with every original physical page image mandatory and authoritative. Exact native PDF text is an incomplete search layer and retains extraction artifacts; original images preserve tables, screenshots, flowcharts and footnotes. Source preservation does not establish consolidated currentness, universal applicability, a new fact, or completion of any QBD scenario. No publication or effective date is inferred from file properties.
MDCG 2018-1 Rev.4 is the official identifier MDCG uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.