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title: "Post-Market Drift Calendar · 7 regulators · AI SaMD"
description: "Pick device class and jurisdictions, get recurring post-market obligations for AI/ML devices: PSUR, PMCF, AI Act, PCCP. Export to ICS."
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[Back to AI SaMD Playbook](/) Post-market obligations · ICS export 

# Post-market _drift_ calendar

Pick a device class and the jurisdictions you sell into. Get every recurring obligation · PSUR, PMCF, MDR vigilance, AI Act post-market reports, PCCP performance monitoring · in one list, then drop them onto your team's calendar with one click.

Device class

Low risk (FDA Class I · MDR Class I · IMDRF I)Moderate risk (FDA Class II · MDR IIa/IIb · IMDRF II/III)High risk (FDA Class III · MDR III · IMDRF IV)

Jurisdictions

United States · FDAEuropean UnionUnited Kingdom · MHRACanada · Health CanadaJapan · PMDAAustralia · TGAChina · NMPA

Export 9 events · .ics

-   United States · FDA
    
    ### Cybersecurity vulnerability monitoring & disclosure
    
    every 1mo 
    
    Continuous · 60-day patch SLA
    
    Basis · FDA Feb 2026 cyber §VI
    
-   United States · FDA
    
    ### MDR adverse-event reporting · 30-day
    
    every 3mo 
    
    Per event (≤30 days)
    
    Basis · 21 CFR 803
    
-   United States · FDA
    
    ### PCCP performance monitoring review
    
    every 3mo 
    
    Per PCCP protocol (typ. quarterly)
    
    Basis · FDA PCCP final §V.C
    
    Subgroup AUROC and calibration vs. cleared envelope.
    
-   European Union
    
    ### Serious incident & FSCA reporting (EUDAMED)
    
    every 6mo 
    
    ≤15 days serious · ≤2 days serious public health threat
    
    Basis · EU MDR Art. 87–89
    
-   European Union
    
    ### Automatically-generated logs retention review
    
    every 6mo 
    
    Continuous · retain ≥6 months
    
    Basis · EU AI Act Art. 19
    
-   United States · FDA
    
    ### Establishment registration & device listing
    
    every 12mo 
    
    Annual (Oct 1 – Dec 31)
    
    Basis · 21 CFR 807
    
-   European Union
    
    ### PSUR (Periodic Safety Update Report)
    
    every 12mo 
    
    Class IIb/III: annual · Class IIa: every 2 years
    
    Basis · EU MDR Art. 86
    
-   European Union
    
    ### PMCF evaluation report update
    
    every 12mo 
    
    Annual review of PMCF plan
    
    Basis · EU MDR Annex XIV Part B
    
-   European Union
    
    ### AI Act post-market monitoring report (high-risk AI)
    
    every 12mo 
    
    Annual to market-surveillance authority
    
    Basis · EU AI Act Art. 72; Art. 73 (serious incidents within 15 days)
    
    Applies from 2 Aug 2026 for high-risk AI systems.
    

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