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MDCG MDCG

MDCG 2022-6

Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR
European UnionMedical Device Coordination GroupRegistrationCurrentness under review
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Document status

Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.

What this code is

MDCG 2022-6 is the official MDCG identifier for “Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR”. MDCG 2022-6 is the official identifier MDCG uses for this instrument.

Instrument
MDCG
Full name
MDCG 2022-6
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Registration
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About this regulation

Guidance on significant changes regarding the transitional provision under Article 110(3) of the IVDR

Complete 17-page nonbinding MDCG guidance, printed May 2022, limited to legacy IVDD devices under the stated IVDR Article 110 transitional scope. Manufacturer-organisation examples, certificate/QMS notification conditions and all decision charts remain intact. Its historical transition dates, including the page 5 May 2025 wording, are preserved but not treated as current deadlines after later legislation. This exact captured system/files URL is not silently aliased to the different UUID link now listed on the official index. No blanket manufacturer-transfer or universal IVDR change route is inferred. 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 2022-6 is the official identifier MDCG uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.

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