MHRA Post-Market Surveillance Regulations 2025 · v2025-06
MHRA Post-Market Surveillance Regulations 2025
MHRA Post-Market Surveillance Regulations 2025 — 100% covered.
36 requirements · 36 enforced · 0 designed · 0 advisory · 0 deferred.
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 | Designed | Advisory | Deferred | Coverage |
|---|---|---|---|---|---|---|
| Incident Reporting Timelines | 7 | 7 | 0 | 0 | 0 | 100% |
| Post-Market Clinical Follow-up (Reg 8) | 4 | 4 | 0 | 0 | 0 | 100% |
| PMS Plan (Reg 7) | 6 | 6 | 0 | 0 | 0 | 100% |
| Post-Market Surveillance | 9 | 9 | 0 | 0 | 0 | 100% |
| Periodic Safety Update Reports (PSURs) | 6 | 6 | 0 | 0 | 0 | 100% |
| Trend Reporting | 4 | 4 | 0 | 0 | 0 | 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.v1engines: internal, internalworkers: kye-incident-detector, kye-reporting-workerconstitution_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.v1engines: internal, internalworkers: kye-incident-detectorconstitution_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.v1engines: internal, internalconstitution_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.v1engines: internal, internalconstitution_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.v1engines: internal, internalconstitution_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.v1engines: internal, internalconstitution_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.v1engines: internalconstitution_refs: constitution/31-DATA-GOVERNANCE-PACK.md |
mhra-pms-2025.pmcf.plan |
Reg 8 — Post-Market Clinical Follow-up (PMCF) plan | enforced | audit_events: kye.assurance.model_validation.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_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.v1engines: internal, internalconstitution_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 | audit_events: kye.assurance.risk_assessment.v1, kye.assurance.review_cycle.v1engines: internal, internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-pms-2025.pmcf.deviation-trigger |
Reg 8 — Trigger update to risk management when PMCF shows deviation | enforced | audit_events: kye.agency_drift.event.v1, kye.resilience.drift.detected.v1engines: internal, internalconstitution_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.v1engines: internal, internalconstitution_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.v1engines: internal, internalconstitution_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.v1engines: internalconstitution_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.v1engines: internalconstitution_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 | audit_events: kye.assurance.review_cycle.v1, kye.compliance.attestation.v1engines: internalconstitution_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.assurance.risk_assessment.v1engines: internal, internaldictionaries: internalconstitution_refs: constitution/29-PROFILES-LITE.md |
mhra-pms-2025.req-1 |
Have a post-market surveillance system in place | enforced | audit_events: kye.compliance.attestation.v1, kye.resilience.drift.detected.v1, kye.agency_drift.event.v1engines: internal, internal, internalworkers: kye-drift-detector, kye-incident-detector, kye-reporting-workerconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-pms-2025.req-2 |
Produce a PMS plan and undertake PMS in accordance with the plan | enforced | audit_events: kye.compliance.attestation.v1, kye.assurance.review_cycle.v1engines: internalworkers: kye-compliance-card-refreshconstitution_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.v1engines: internal, internalworkers: kye-incident-detector, kye-webhook-dispatchercomms_templates: audit-pilot.admin-alert.v1constitution_refs: constitution/38-COMMS-RAIL.md |
mhra-pms-2025.req-4 |
Investigate serious incidents and report to MHRA on conclusions | enforced | audit_events: kye.assurance.audit_replay_report.v1, kye.resilience.improvement.v1, kye.resilience.improvement_record.v1engines: internal, internalworkers: kye-audit-replay-orchestrator, kye-reporting-workerconstitution_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.v1engines: internal, internal, internalworkers: kye-revocation-cascadeconstitution_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.v1engines: internal, internalworkers: kye-incident-detector, kye-webhook-dispatchercomms_templates: audit-pilot.admin-alert.v1, audit-pilot.applicant-confirmation.v1constitution_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 | audit_events: kye.report.quarterly_drift.v1, kye.report.monthly_decision_summary.v1, kye.resilience.measurement_record.v1engines: internal, internalworkers: kye-reporting-workerconstitution_refs: constitution/20-ANALYTICS-PLANE.md |
mhra-pms-2025.req-8 |
Produce a PMS safety report or periodic safety update report (PSUR) | enforced | audit_events: kye.report.annual_conformance_attestation.v1, kye.compliance.attestation.v1engines: internalworkers: kye-reporting-worker, kye-compliance-card-refreshconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-pms-2025.req-9 |
Meet documentation and information provision requirements | enforced | audit_events: kye.audit.event.appended.v1, kye.evidence.pack.v1engines: internal, internalworkers: kye-audit-chain-worker, kye-evidence-pack-assemblerconstitution_refs: constitution/30-AUDIT-WORM-RETENTION.md |
mhra-pms-2025.psur.cadence-class-iia |
PSUR every 2 years for Class IIa devices | enforced | audit_events: kye.assurance.review_cycle.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-pms-2025.psur.cadence-class-iib-iii |
PSUR annually for Class IIb / III devices | enforced | audit_events: kye.assurance.review_cycle.v1, kye.compliance.attestation.v1engines: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-pms-2025.psur.content-conclusions |
PSUR conclusions section — benefit-risk + actions taken | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.evidence.pack.v1engines: internal, internalconstitution_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.v1engines: internal, internalconstitution_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.dispatch.v1engines: internalconstitution_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.v1engines: internalconstitution_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.v1engines: internalworkers: kye-drift-detectorconstitution_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.v1engines: internal, internalconstitution_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.v1engines: internalworkers: kye-reporting-workerconstitution_refs: constitution/38-COMMS-RAIL.md |
mhra-pms-2025.tr.update-pms-plan |
Update PMS plan in light of trend findings | enforced | audit_events: kye.assurance.review_cycle.v1, kye.compliance.attestation.v1engines: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |