MDCG MDCGMDCG 2020-3 Rev.1
Currentness under review. Whether this instrument remains applicable is under review. Consult the later instruments and source context below before relying on it.
MDCG 2020-3 Rev.1 is the official MDCG identifier for “Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD”. MDCG 2020-3 Rev.1 is the official identifier MDCG uses for this instrument.
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- MDCG 2020-3 Rev.1
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Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD
Complete 21-page nonbinding MDCG guidance, printed May 2023. The current official index labels this expression September 2023 and warns about the temporarily displayed 7–8 September version; these observations are kept distinct rather than inventing a publication date. Limited to legacy MDD/AIMDD devices and MDR Article 120 transitional conditions. Page 5 footnote 17 limits the name/address/legal-form example to cases where the certified legal entity continues to exist; transfer to another manufacturer placing devices under MDR is expressly outside that example. Notified-body/QMS conditions remain applicable. No general MDR approval, fee, clock, old-stock or combined-application conclusion. 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 2020-3 Rev.1 is the official identifier MDCG uses for this instrument. Always confirm the current consolidated text and transition provisions with the official source before filing.