MHRA Medical Devices Regulations 2002 · v2002-as-amended-2024
MHRA Medical Devices Regulations 2002
MHRA Medical Devices Regulations 2002 — 97% covered.
53 requirements · 50 enforced · 3 designed · 0 advisory · 0 deferred.
Source: UK Statutory Instrument 2002/618 — Medical Devices Regulations 2002, as amended
By category
| Category | Reqs | Enforced | Designed | Advisory | Deferred | Coverage |
|---|---|---|---|---|---|---|
| Classification Rules (Annex IX) | 10 | 10 | 0 | 0 | 0 | 100% |
| Conformity Assessment (declaration / Approved Body / registration) | 11 | 10 | 1 | 0 | 0 | 95% |
| Essential Requirements (Annex I, regs 7-12) | 12 | 12 | 0 | 0 | 0 | 100% |
| Post-Market Vigilance (regs 44-47) | 8 | 8 | 0 | 0 | 0 | 100% |
| Risk classes (Class I / IIa / IIb / III + software class) | 12 | 10 | 2 | 0 | 0 | 92% |
Every requirement → the KYE™ artefact that enforces it
| ID | Title | Status | KYE™ enforcement |
|---|---|---|---|
mhra-mdr-2002.cls.rule-9-active-therapeutic |
Annex IX Rule 9 — Active therapeutic devices (energy delivery) | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.compliance.attestation.v1engines: internal, internaldictionaries: internalconstitution_refs: constitution/29-PROFILES-LITE.md |
mhra-mdr-2002.cls.rule-10-active-diagnostic |
Annex IX Rule 10 — Active diagnostic devices | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_refs: constitution/29-PROFILES-LITE.md |
mhra-mdr-2002.cls.rule-11-software-decisions |
MDR Rule 11 — Software for decisions impacting therapy/diagnosis (covers most clinical SaMD) | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.model.capability_profile.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_refs: constitution/29-PROFILES-LITE.md |
mhra-mdr-2002.cls.rule-15-IVD-disinfection |
Annex IX Rule 15 — Devices for disinfection/cleaning of medical devices | enforced | audit_events: kye.assurance.risk_assessment.v1engines: internalconstitution_refs: constitution/29-PROFILES-LITE.md |
mhra-mdr-2002.cls.intended-purpose-binding |
Intended purpose binding — class flows from declared intended purpose | enforced | audit_events: kye.model.capability_profile.v1, kye.purpose.permission.v1engines: internal, internalconstitution_refs: constitution/12-PURPOSE-PERMISSION.md |
mhra-mdr-2002.cls.borderline-products |
Borderline products (drug/device, software/lifestyle) — qualification decision | enforced | audit_events: kye.assurance.audit_pilot.v1, kye.evidence.decision_map.v1engines: internalconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.cls.accessory |
Accessory to a medical device — class follows its host | enforced | audit_events: kye.assurance.risk_assessment.v1engines: internalconstitution_refs: constitution/29-PROFILES-LITE.md |
mhra-mdr-2002.cls.implementing-rules |
Implementing rules — highest applicable class when multiple rules apply | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_refs: constitution/29-PROFILES-LITE.md |
mhra-mdr-2002.cls.class-change-on-update |
Re-classification trigger when intended purpose/capability changes | enforced | audit_events: kye.model.influence_envelope.v1, kye.agency_drift.event.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.cls.class-evidence-recorded |
Classification decision recorded in technical documentation | enforced | audit_events: kye.evidence.decision_map.v1, kye.evidence.pack.v1engines: internal, internalconstitution_refs: constitution/30-AUDIT-WORM-RETENTION.md |
mhra-mdr-2002.ca.manufacturer-declaration |
Manufacturer Declaration of Conformity (DoC) | enforced | audit_events: kye.compliance.attestation.v1, kye.evidence.signature.v1engines: internal, internalworkers: kye-compliance-card-refreshconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.ca.MHRA-registration |
MHRA device registration (legal manufacturer + UKRP) | enforced | audit_events: kye.compliance.attestation.v1engines: internal, internalworkers: kye-reporting-workerconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.ca.UKRP-designation |
UK Responsible Person designated (if outside UK) | enforced | audit_events: kye.assurance.management_review.v1engines: internalgovernedui_modules: kye.governedui.module.entity_passport.v1constitution_refs: constitution/36-GOVERNEDUI.md |
mhra-mdr-2002.ca.approved-body-assessment |
Approved Body assessment for IIa/IIb/III + active implantables | enforced | audit_events: kye.assurance.audit_pilot.v1, kye.evidence.pack.v1engines: internalagents: internalworkers: kye-audit-pilot-agentconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.ca.QMS-required |
Quality Management System (ISO 13485 equivalent) | enforced | audit_events: kye.compliance.attestation.v1, kye.assurance.management_review.v1workers: kye-compliance-card-refreshconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.ca.technical-file |
Technical-file completeness | enforced | audit_events: kye.evidence.pack.v1engines: internalworkers: kye-evidence-pack-assemblerconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.ca.design-dossier |
Design dossier (Class IIb / III) | enforced | audit_events: kye.evidence.pack.v1, kye.assurance.model_validation.v1engines: internal, internalworkers: kye-evidence-pack-assembler, kye-conformance-runnerconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.ca.declaration-WORM |
Declaration of Conformity WORM-archived | enforced | audit_events: kye.audit.event.appended.v1, kye.compliance.attestation.v1engines: internalworkers: kye-audit-chain-workerconstitution_refs: constitution/30-AUDIT-WORM-RETENTION.md |
mhra-mdr-2002.ca.substantial-change-reassessment |
Re-assessment on substantial change | enforced | audit_events: kye.resilience.drift.detected.v1, kye.assurance.model_validation.v1engines: internal, internalworkers: kye-drift-detectorconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.ca.labelling-info |
Labelling and information supplied with device | designed | audit_events: kye.consent.receipt.v1, kye.agent.workflow.v1comms_templates: expert-review.brief.v1constitution_refs: constitution/38-COMMS-RAIL.md |
mhra-mdr-2002.ca.clinical-investigation |
Clinical investigation evidence (if applicable) | enforced | audit_events: kye.evidence.pack.v1, kye.evidence.healthcare.cdss.v1engines: internalworkers: kye-evidence-pack-assemblersector_packs: kye:sector-pack:healthcareconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.er.reg-7-general-safety |
Regulation 7 — Essential Requirements: general safety, performance, and acceptable risk-benefit | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.assurance.model_validation.v1, kye.compliance.attestation.v1engines: internal, internalworkers: kye-conformance-runnerconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.er.reg-8-risk-management-process |
Regulation 8 — Risk management process (identify, evaluate, control, monitor) | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.resilience.drift.detected.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.er.reg-8-residual-risk-disclosure |
Disclose residual risk + intended-use restrictions in labelling and Instructions for Use | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.compliance.attestation.v1engines: internalconstitution_refs: constitution/38-COMMS-RAIL.md |
mhra-mdr-2002.er.reg-9-design-and-construction |
Regulation 9 — Design + construction conform to safety principles (chemical, physical, biological) | enforced | audit_events: kye.assurance.model_validation.v1, kye.compliance.attestation.v1engines: internalworkers: kye-conformance-runnerconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.er.reg-10-information-supplied |
Regulation 10 — Information supplied by the manufacturer (label + IFU) | enforced | audit_events: kye.compliance.attestation.v1engines: internalconstitution_refs: constitution/38-COMMS-RAIL.md |
mhra-mdr-2002.er.reg-11-software-lifecycle |
Regulation 11 — Software lifecycle: validation, verification, configuration management (IEC 62304 aligned) | enforced | audit_events: kye.assurance.model_validation.v1, kye.evidence.model_params.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_refs: constitution/30-AUDIT-WORM-RETENTION.md |
mhra-mdr-2002.er.reg-11-cybersecurity |
Regulation 11 (software) — cybersecurity considerations across the lifecycle | enforced | audit_events: kye.signal.incident.opened.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_refs: constitution/25-EDGE-GOVERNANCE.md |
mhra-mdr-2002.er.reg-12-clinical-evaluation |
Regulation 12 — Clinical evaluation (pre-market clinical data review) | enforced | audit_events: kye.assurance.model_validation.v1, kye.evidence.pack.v1engines: internal, internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.er.reg-12-clinical-investigation |
Regulation 12 — Clinical investigation governance (when clinical data is insufficient) | enforced | audit_events: kye.assurance.audit_pilot.v1, kye.compliance.attestation.v1engines: internalconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.er.usability-engineering |
Annex I — Usability engineering (IEC 62366 aligned, use-error risk) | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.governedui.critical_point_review.v1engines: internalconstitution_refs: constitution/36-GOVERNEDUI.md |
mhra-mdr-2002.er.ai-validation-data |
Essential Requirement — AI/ML algorithm validation data + acceptance criteria | enforced | audit_events: kye.assurance.model_validation.v1, kye.evidence.model_params.v1, kye.model.capability_profile.v1engines: internal, internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.er.ai-explainability |
Essential Requirement — Explainability commensurate with clinical risk | enforced | audit_events: kye.evidence.decision_map.v1, kye.evidence.trace_replay_spec.v1engines: internal, internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.pm.reg-44-incident-reporting |
Regulation 44 — Manufacturer incident reporting to MHRA | enforced | audit_events: kye.signal.incident.opened.v1, kye.signal.incident.closed.v1, kye.compliance.attestation.v1engines: internal, internalworkers: kye-incident-detector, kye-reporting-workerconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.pm.reg-44-serious-incident-timeline |
Regulation 44 — Serious incident reporting within statutory timelines (10/15-day) | enforced | audit_events: kye.signal.incident.opened.v1, kye.compliance.attestation.v1engines: internal, internalworkers: kye-incident-detectorconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.pm.reg-45-trending |
Regulation 45 — Trend reporting (non-serious but statistically significant) | enforced | audit_events: kye.signal.drift.detected.v1, kye.resilience.drift.detected.v1engines: internal, internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.pm.reg-46-FSCA |
Regulation 46 — Field Safety Corrective Action notification | enforced | audit_events: kye.compliance.attestation.v1, kye.comms.dispatch.v1engines: internalconstitution_refs: constitution/38-COMMS-RAIL.md |
mhra-mdr-2002.pm.reg-47-FSN |
Regulation 47 — Field Safety Notice to users/customers | enforced | audit_events: kye.comms.dispatch.v1, kye.compliance.attestation.v1engines: internalconstitution_refs: constitution/38-COMMS-RAIL.md |
mhra-mdr-2002.pm.MIR-vigilance |
Manufacturer Incident Report (MIR) — content + WORM retention | enforced | audit_events: kye.signal.incident.opened.v1, kye.evidence.pack.v1engines: internal, internalconstitution_refs: constitution/30-AUDIT-WORM-RETENTION.md |
mhra-mdr-2002.pm.periodic-summary-update |
Periodic Safety Update Report (PSUR) cadence and content | enforced | audit_events: kye.assurance.tier1_readiness.v1, kye.compliance.attestation.v1engines: internal, internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.pm.market-surveillance-cooperation |
Cooperation with MHRA market-surveillance enquiries | enforced | audit_events: kye.assurance.audit_pilot.v1, kye.compliance.attestation.v1engines: internal, internalagents: internalconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.rc.class-I |
Class I (low-risk) self-declaration of conformity | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.compliance.attestation.v1engines: internal, internaldictionaries: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.rc.class-IIa |
Class IIa medium-risk — Approved Body assessment required | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.assurance.audit_pilot.v1engines: internal, internalagents: internalworkers: kye-audit-pilot-agentconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.rc.class-IIb |
Class IIb higher-medium-risk — Approved Body + design dossier | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.assurance.model_validation.v1, kye.assurance.audit_pilot.v1engines: internal, internalworkers: kye-audit-pilot-agent, kye-conformance-runnerconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.rc.class-III |
Class III high-risk — full Approved-Body QA + design examination | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.assurance.model_validation.v1, kye.assurance.audit_pilot.v1, kye.evidence.pack.v1engines: internal, internal, internalworkers: kye-audit-pilot-agent, kye-conformance-runner, kye-evidence-pack-assemblerconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.rc.software-classification |
Software-as-medical-device classification (MEDDEV / Rule 11) | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.assurance.model_validation.v1engines: internal, internaldictionaries: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.rc.ai-saMD-classification |
AI-SaMD classification per Change Program alignment | enforced | audit_events: kye.assurance.risk_assessment.v1, kye.assurance.adoption_stage.v1engines: internalconstitution_refs: constitution/13-RESILIENCE-LOOP.md |
mhra-mdr-2002.rc.intended-purpose-statement |
Intended Purpose Statement declared | enforced | audit_events: kye.assurance.model_validation.v1engines: internalgovernedui_modules: kye.governedui.module.entity_passport.v1constitution_refs: constitution/36-GOVERNEDUI.md |
mhra-mdr-2002.rc.essential-requirements |
Essential requirements (safety, performance, info-supplied) | enforced | audit_events: kye.compliance.attestation.v1, kye.assurance.model_validation.v1engines: internalworkers: kye-compliance-card-refreshconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.rc.clinical-evaluation |
Clinical evaluation report | enforced | audit_events: kye.assurance.model_validation.v1, kye.evidence.pack.v1, kye.evidence.healthcare.cdss.v1engines: internal, internalworkers: kye-evidence-pack-assemblersector_packs: kye:sector-pack:healthcareconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.rc.technical-documentation |
Technical documentation (file kept by manufacturer) | enforced | audit_events: kye.evidence.pack.v1, kye.audit.event.appended.v1engines: internal, internalworkers: kye-evidence-pack-assembler, kye-audit-chain-workerconstitution_refs: constitution/30-AUDIT-WORM-RETENTION.md |
mhra-mdr-2002.rc.UKCA-marking |
UKCA / UK Conformity-Assessment marking | designed | audit_events: kye.compliance.attestation.v1, kye.assurance.ato.v1workers: kye-compliance-card-refreshconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |
mhra-mdr-2002.rc.CE-NI |
CE marking for Northern Ireland (per NI Protocol) | designed | audit_events: kye.compliance.attestation.v1workers: kye-compliance-card-refreshconstitution_refs: constitution/21-DELEGATED-AUDITABILITY.md |