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