MHRA Post-Market Surveillance Regulations 2025

MHRA Post-Market Surveillance Regulations 2025 — 100% of in-scope requirements covered.

36 requirements · 36 in scope (36 enforced). The 100% is weighted over the in-scope base.

MHRA Post-Market Surveillance Regulations 2025: requirement → the KYE™ artefact that enforces it

Demo data

You learn: Which requirements KYE™ enforces at runtime and with which artefact. You can: Walk the requirements.

serious-incident-15-day · enforced

Serious incident reporting within 15 days
Audit events: kye.signal.incident.opened.v1, kye.compliance.attestation.v1 · Workers: kye-incident-detector, kye-reporting-worker · Constitution: 13 resilience loop
death-or-serious-injury-10-day · enforced

Death / serious health deterioration — 10-day reporting
Audit events: kye.signal.incident.opened.v1, kye.compliance.attestation.v1 · Workers: kye-incident-detector · Constitution: 13 resilience loop
public-health-threat-2-day · enforced

Serious public-health threat — 2-day reporting
Audit events: kye.signal.incident.opened.v1, kye.compliance.attestation.v1 · Constitution: 25 edge governance
investigation-record · enforced

Investigate incidents + record root cause
Audit events: kye.evidence.decision_map.v1, kye.evidence.trace_replay_spec.v1 · Constitution: 13 resilience loop
corrective-action · enforced

Corrective + preventive action plan after incident
Audit events: kye.signal.incident.closed.v1, kye.compliance.attestation.v1 · Constitution: 13 resilience loop
final-report-30-day · enforced

Final incident report within statutory window
Audit events: kye.signal.incident.closed.v1, kye.evidence.pack.v1 · Constitution: 30 audit worm retention

How this widget is built

Demonstrates

KYE™ Compliance Mapping Rail™

Components

Framework requirement (clause)
Coverage status
KYE™ enforcement artefact (event, decision-record field, Evidence Pack™ entry)

Flow

Clause → status → the KYE™ artefact that enforces it, enforced requirements first. Architecture diagram

Used on

/compliance/mhra-pms-2025/: On every framework page, after its opening.

Source: MHRA Post-Market Surveillance Regulations 2025 (effective June 2025) — UK Statutory Instrument amending MDR 2002 with explicit PMS obligations

By category

Category	Reqs	Enforced	Coverage
Incident Reporting Timelines	7	7	100%
Post-Market Clinical Follow-up (Reg 8)	4	4	100%
PMS Plan (Reg 7)	6	6	100%
Post-Market Surveillance	9	9	100%
Periodic Safety Update Reports (PSURs)	6	6	100%
Trend Reporting	4	4	100%

Every requirement → the KYE™ artefact that enforces it

ID	Title	Status	KYE™ enforcement
`mhra-pms-2025.ir.serious-incident-15-day`	Serious incident reporting within 15 days	enforced	audit_events: `kye.signal.incident.opened.v1`, `kye.compliance.attestation.v1` engines: `internal`, `internal` workers: `kye-incident-detector`, `kye-reporting-worker` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.ir.death-or-serious-injury-10-day`	Death / serious health deterioration — 10-day reporting	enforced	audit_events: `kye.signal.incident.opened.v1`, `kye.compliance.attestation.v1` engines: `internal`, `internal` workers: `kye-incident-detector` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.ir.public-health-threat-2-day`	Serious public-health threat — 2-day reporting	enforced	audit_events: `kye.signal.incident.opened.v1`, `kye.compliance.attestation.v1` engines: `internal`, `internal` constitution_refs: `constitution/25-EDGE-GOVERNANCE.md`
`mhra-pms-2025.ir.investigation-record`	Investigate incidents + record root cause	enforced	audit_events: `kye.evidence.decision_map.v1`, `kye.evidence.trace_replay_spec.v1` engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.ir.corrective-action`	Corrective + preventive action plan after incident	enforced	audit_events: `kye.signal.incident.closed.v1`, `kye.compliance.attestation.v1` engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.ir.final-report-30-day`	Final incident report within statutory window	enforced	audit_events: `kye.signal.incident.closed.v1`, `kye.evidence.pack.v1` engines: `internal`, `internal` constitution_refs: `constitution/30-AUDIT-WORM-RETENTION.md`
`mhra-pms-2025.ir.confidentiality`	Patient confidentiality maintained in incident records	enforced	audit_events: `kye.data_access_evidence_event.v1` engines: `internal` constitution_refs: `constitution/31-DATA-GOVERNANCE-PACK.md`
`mhra-pms-2025.pmcf.plan`	Reg 8 — Post-Market Clinical Follow-up (PMCF) plan	enforced 1 unverified citation	audit_events: `kye.assurance.model_validation.v1` unverified citation, `kye.compliance.attestation.v1` engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.pmcf.real-world-performance`	Reg 8 — Real-world performance monitoring + clinical outcomes review	enforced	audit_events: `kye.evidence.observed_action.v1`, `kye.signal.drift.detected.v1` engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.pmcf.benefit-risk-update`	Reg 8 — Periodic benefit-risk re-evaluation in light of PMCF data	enforced 1 unverified citation	audit_events: `kye.risk_assessment.v1`, `kye.assurance.review_cycle.v1` unverified citation engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.pmcf.deviation-trigger`	Reg 8 — Trigger update to risk management when PMCF shows deviation	enforced 1 unverified citation	audit_events: `kye.agency_drift.event.v1`, `kye.resilience.drift.detected.v1` unverified citation engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.plan.objectives`	Reg 7 — PMS plan must define objectives and scope per device	enforced	audit_events: `kye.purpose.permission.v1`, `kye.compliance.attestation.v1` engines: `internal`, `internal` constitution_refs: `constitution/12-PURPOSE-PERMISSION.md`
`mhra-pms-2025.plan.data-sources`	Reg 7 — Identify proactive + reactive PMS data sources	enforced	audit_events: `kye.evidence.observed_action.v1`, `kye.signal.drift.detected.v1` engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.plan.indicator-thresholds`	Reg 7 — Define indicators + thresholds for triggering action	enforced	audit_events: `kye.model.influence_envelope.v1`, `kye.signal.drift.detected.v1` engines: `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.plan.responsibilities`	Reg 7 — Designate qualified person responsible for PMS	enforced	audit_events: `kye.governedui.approval.v1` engines: `internal` constitution_refs: `constitution/36-GOVERNEDUI.md`
`mhra-pms-2025.plan.review-cadence`	Reg 7 — Define PMS plan review cadence (at least annual for Class IIa+)	enforced 1 unverified citation	audit_events: `kye.assurance.review_cycle.v1` unverified citation, `kye.compliance.attestation.v1` engines: `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.plan.proportionate-to-class`	Reg 7 — PMS activities proportionate to risk class	enforced	audit_events: `kye.risk_assessment.v1` engines: `internal`, `internal` dictionaries: `internal` constitution_refs: `constitution/29-PROFILES-LITE.md`
`mhra-pms-2025.req-1`	Have a post-market surveillance system in place	enforced 1 unverified citation	audit_events: `kye.compliance.attestation.v1`, `kye.resilience.drift.detected.v1` unverified citation, `kye.agency_drift.event.v1` engines: `internal`, `internal`, `internal` workers: `kye-drift-detector`, `kye-incident-detector`, `kye-reporting-worker` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.req-2`	Produce a PMS plan and undertake PMS in accordance with the plan	enforced 1 unverified citation	audit_events: `kye.compliance.attestation.v1`, `kye.assurance.review_cycle.v1` unverified citation engines: `internal` workers: `kye-compliance-card-refresh` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.req-3`	Report serious incidents to MHRA	enforced	audit_events: `kye.audit.event.v1`, `kye.agency_drift.event.v1` engines: `internal`, `internal` workers: `kye-incident-detector`, `kye-webhook-dispatcher` comms_templates: `audit-pilot.admin-alert.v1` constitution_refs: `constitution/38-COMMS-RAIL.md`
`mhra-pms-2025.req-4`	Investigate serious incidents and report to MHRA on conclusions	enforced 1 unverified citation	audit_events: `kye.assurance.audit_replay_report.v1`, `kye.resilience.improvement.v1` unverified citation, `kye.resilience.improvement_record.v1` engines: `internal`, `internal` workers: `kye-audit-replay-orchestrator`, `kye-reporting-worker` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.req-5`	Undertake preventative and corrective actions as required	enforced	audit_events: `kye.resilience.improvement_record.v1`, `kye.resilience.loop_iteration.v1`, `kye.operating_model.guard_recommendation.v1` engines: `internal`, `internal`, `internal` workers: `kye-revocation-cascade` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.req-6`	Undertake field safety corrective actions and issue field safety notices	enforced	audit_events: `kye.audit.event.v1`, `kye.resilience.improvement_record.v1` engines: `internal`, `internal` workers: `kye-incident-detector`, `kye-webhook-dispatcher` comms_templates: `audit-pilot.admin-alert.v1`, `audit-pilot.applicant-confirmation.v1` constitution_refs: `constitution/38-COMMS-RAIL.md`
`mhra-pms-2025.req-7`	Conduct trend reporting of significant increases in incidents that do not require reporting	enforced 3 unverified citations	audit_events: `kye.report.quarterly_drift.v1` unverified citation, `kye.report.monthly_decision_summary.v1` unverified citation, `kye.resilience.measurement_record.v1` unverified citation engines: `internal`, `internal` workers: `kye-reporting-worker` constitution_refs: `constitution/20-ANALYTICS-PLANE.md`
`mhra-pms-2025.req-8`	Produce a PMS safety report or periodic safety update report (PSUR)	enforced 1 unverified citation	audit_events: `kye.report.annual_conformance_attestation.v1` unverified citation, `kye.compliance.attestation.v1` engines: `internal` workers: `kye-reporting-worker`, `kye-compliance-card-refresh` constitution_refs: `constitution/21-DELEGATED-AUDITABILITY.md`
`mhra-pms-2025.req-9`	Meet documentation and information provision requirements	enforced 1 unverified citation	audit_events: `kye.audit.event.appended.v1` unverified citation, `kye.evidence.pack.v1` engines: `internal`, `internal` workers: `kye-audit-chain-worker`, `kye-evidence-pack-assembler` constitution_refs: `constitution/30-AUDIT-WORM-RETENTION.md`
`mhra-pms-2025.psur.cadence-class-iia`	PSUR every 2 years for Class IIa devices	enforced 1 unverified citation	audit_events: `kye.assurance.review_cycle.v1` unverified citation, `kye.compliance.attestation.v1` engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.psur.cadence-class-iib-iii`	PSUR annually for Class IIb / III devices	enforced 1 unverified citation	audit_events: `kye.assurance.review_cycle.v1` unverified citation, `kye.compliance.attestation.v1` engines: `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.psur.content-conclusions`	PSUR conclusions section — benefit-risk + actions taken	enforced	audit_events: `kye.risk_assessment.v1`, `kye.evidence.pack.v1` engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.psur.statistics`	PSUR statistical summary (usage, complaints, incident rates)	enforced	audit_events: `kye.evidence.observed_action.v1` engines: `internal`, `internal` constitution_refs: `constitution/20-ANALYTICS-PLANE.md`
`mhra-pms-2025.psur.submission-to-approved-body`	PSUR submitted to Approved Body (Class IIa-III)	enforced	audit_events: `kye.compliance.attestation.v1`, `kye.comms.dispatched.v1` engines: `internal` constitution_refs: `constitution/38-COMMS-RAIL.md`
`mhra-pms-2025.psur.WORM-retention-10y`	PSUR retained 10 years post-cessation of device sale	enforced	audit_events: `kye.evidence.pack.v1` engines: `internal` constitution_refs: `constitution/30-AUDIT-WORM-RETENTION.md`
`mhra-pms-2025.tr.statistical-trend-monitoring`	Statistical trend monitoring of non-serious incidents	enforced	audit_events: `kye.signal.drift.detected.v1`, `kye.signal.stable_drift.detected.v1` engines: `internal` workers: `kye-drift-detector` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.tr.trend-report-threshold`	Trend report when frequency/severity exceeds plan threshold	enforced	audit_events: `kye.signal.drift.detected.v1`, `kye.model.influence_envelope.v1` engines: `internal`, `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`
`mhra-pms-2025.tr.30-day-reporting`	Trend report submission within 30 days of detection	enforced	audit_events: `kye.compliance.attestation.v1` engines: `internal` workers: `kye-reporting-worker` constitution_refs: `constitution/38-COMMS-RAIL.md`
`mhra-pms-2025.tr.update-pms-plan`	Update PMS plan in light of trend findings	enforced 1 unverified citation	audit_events: `kye.assurance.review_cycle.v1` unverified citation, `kye.compliance.attestation.v1` engines: `internal` constitution_refs: `constitution/13-RESILIENCE-LOOP.md`

Canonical KYE™ surfaces referenced on this page: KYE Protocol™.

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