---
title: "MHRA Medical Devices Regulations 2002 — KYE Protocol™ coverage"
description: "MHRA Medical Devices Regulations 2002 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it."
url: https://kyeprotocol.com/compliance/mhra-mdr-2002/
lang: en
source: "KYE Protocol"
---

> MHRA Medical Devices Regulations 2002 coverage by KYE Protocol™ — every requirement bijection-mapped to the KYE™ artefact that enforces it.

MHRA Medical Devices Regulations 2002

# MHRA Medical Devices Regulations 2002 — 97% of in-scope requirements covered.

53 requirements · 53 in scope (50 enforced · 3 designed). The 97% is weighted over the in-scope base.

**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.risk_assessment.v1`, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **dictionaries**: `internal` **constitution\_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.risk_assessment.v1`, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **constitution\_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.risk_assessment.v1`, `kye.model.capability_profile.v1`, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **constitution\_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.risk_assessment.v1` **engines**: `internal` **constitution\_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.v1` **engines**: `internal`, `internal` **constitution\_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.v1` **engines**: `internal` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.cls.accessory` | Accessory to a medical device — class follows its host | enforced | **audit\_events**: `kye.risk_assessment.v1` **engines**: `internal` **constitution\_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.risk_assessment.v1`, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **constitution\_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.v1` **engines**: `internal`, `internal` **constitution\_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.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/30-AUDIT-WORM-RETENTION.md` |
| `mhra-mdr-2002.ca.manufacturer-declaration` | Manufacturer Declaration of Conformity (DoC) | enforced 1 unverified citation | **audit\_events**: `kye.compliance.attestation.v1`, `kye.evidence.signature.v1` unverified citation **engines**: `internal`, `internal` **workers**: `kye-compliance-card-refresh` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.ca.MHRA-registration` | MHRA device registration (legal manufacturer + UKRP) | enforced | **audit\_events**: `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **workers**: `kye-reporting-worker` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.ca.UKRP-designation` | UK Responsible Person designated (if outside UK) | enforced 1 unverified citation | **audit\_events**: `kye.assurance.management_review.v1` unverified citation **engines**: `internal` **governedui\_modules**: `kye.governedui.module.entity_passport.v1` **constitution\_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.v1` **engines**: `internal` **agents**: `internal` **workers**: `kye-audit-pilot-agent` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.ca.QMS-required` | Quality Management System (ISO 13485 equivalent) | enforced 1 unverified citation | **audit\_events**: `kye.compliance.attestation.v1`, `kye.assurance.management_review.v1` unverified citation **workers**: `kye-compliance-card-refresh` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.ca.technical-file` | Technical-file completeness | enforced | **audit\_events**: `kye.evidence.pack.v1` **engines**: `internal` **workers**: `kye-evidence-pack-assembler` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.ca.design-dossier` | Design dossier (Class IIb / III) | enforced 1 unverified citation | **audit\_events**: `kye.evidence.pack.v1`, `kye.assurance.model_validation.v1` unverified citation **engines**: `internal`, `internal` **workers**: `kye-evidence-pack-assembler`, `kye-conformance-runner` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.ca.declaration-WORM` | Declaration of Conformity WORM-archived | enforced 1 unverified citation | **audit\_events**: `kye.audit.event.appended.v1` unverified citation, `kye.compliance.attestation.v1` **engines**: `internal` **workers**: `kye-audit-chain-worker` **constitution\_refs**: `constitution/30-AUDIT-WORM-RETENTION.md` |
| `mhra-mdr-2002.ca.substantial-change-reassessment` | Re-assessment on substantial change | enforced 2 unverified citations | **audit\_events**: `kye.resilience.drift.detected.v1` unverified citation, `kye.assurance.model_validation.v1` unverified citation **engines**: `internal`, `internal` **workers**: `kye-drift-detector` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-mdr-2002.ca.labelling-info` | Labelling and information supplied with device | designed 1 unverified citation | **audit\_events**: `kye.consent.receipt.v1` unverified citation, `kye.agent.workflow.v1` **comms\_templates**: `expert-review.brief.v1` **constitution\_refs**: `constitution/38-COMMS-RAIL.md` |
| `mhra-mdr-2002.ca.clinical-investigation` | Clinical investigation evidence (if applicable) | enforced 1 unverified citation | **audit\_events**: `kye.evidence.pack.v1`, `kye.evidence.healthcare.cdss.v1` unverified citation **engines**: `internal` **workers**: `kye-evidence-pack-assembler` **sector\_packs**: `kye:sector-pack:healthcare` **constitution\_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 1 unverified citation | **audit\_events**: `kye.risk_assessment.v1`, `kye.assurance.model_validation.v1` unverified citation, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **workers**: `kye-conformance-runner` **constitution\_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 1 unverified citation | **audit\_events**: `kye.risk_assessment.v1`, `kye.resilience.drift.detected.v1` unverified citation, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **constitution\_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.risk_assessment.v1`, `kye.compliance.attestation.v1` **engines**: `internal` **constitution\_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 1 unverified citation | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation, `kye.compliance.attestation.v1` **engines**: `internal` **workers**: `kye-conformance-runner` **constitution\_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.v1` **engines**: `internal` **constitution\_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 1 unverified citation | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation, `kye.evidence.model_params.v1`, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **constitution\_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.v1` **engines**: `internal`, `internal` **constitution\_refs**: `constitution/25-EDGE-GOVERNANCE.md` |
| `mhra-mdr-2002.er.reg-12-clinical-evaluation` | Regulation 12 — Clinical evaluation (pre-market clinical data review) | enforced 1 unverified citation | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation, `kye.evidence.pack.v1` **engines**: `internal`, `internal` **constitution\_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.v1` **engines**: `internal` **constitution\_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.risk_assessment.v1`, `kye.governedui.critical_point_review.v1` **engines**: `internal` **constitution\_refs**: `constitution/36-GOVERNEDUI.md` |
| `mhra-mdr-2002.er.ai-validation-data` | Essential Requirement — AI/ML algorithm validation data + acceptance criteria | enforced 1 unverified citation | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation, `kye.evidence.model_params.v1`, `kye.model.capability_profile.v1` **engines**: `internal`, `internal` **constitution\_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.v1` **engines**: `internal`, `internal` **constitution\_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.v1` **engines**: `internal`, `internal` **workers**: `kye-incident-detector`, `kye-reporting-worker` **constitution\_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.v1` **engines**: `internal`, `internal` **workers**: `kye-incident-detector` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-mdr-2002.pm.reg-45-trending` | Regulation 45 — Trend reporting (non-serious but statistically significant) | enforced 1 unverified citation | **audit\_events**: `kye.signal.drift.detected.v1`, `kye.resilience.drift.detected.v1` unverified citation **engines**: `internal`, `internal` **constitution\_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.dispatched.v1` **engines**: `internal` **constitution\_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.dispatched.v1`, `kye.compliance.attestation.v1` **engines**: `internal` **constitution\_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.v1` **engines**: `internal`, `internal` **constitution\_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.v1` **engines**: `internal`, `internal` **constitution\_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.v1` **engines**: `internal`, `internal` **agents**: `internal` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.rc.class-I` | Class I (low-risk) self-declaration of conformity | enforced | **audit\_events**: `kye.risk_assessment.v1`, `kye.compliance.attestation.v1` **engines**: `internal`, `internal` **dictionaries**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-mdr-2002.rc.class-IIa` | Class IIa medium-risk — Approved Body assessment required | enforced | **audit\_events**: `kye.risk_assessment.v1`, `kye.assurance.audit_pilot.v1` **engines**: `internal`, `internal` **agents**: `internal` **workers**: `kye-audit-pilot-agent` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.rc.class-IIb` | Class IIb higher-medium-risk — Approved Body + design dossier | enforced 1 unverified citation | **audit\_events**: `kye.risk_assessment.v1`, `kye.assurance.model_validation.v1` unverified citation, `kye.assurance.audit_pilot.v1` **engines**: `internal`, `internal` **workers**: `kye-audit-pilot-agent`, `kye-conformance-runner` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.rc.class-III` | Class III high-risk — full Approved-Body QA + design examination | enforced 1 unverified citation | **audit\_events**: `kye.risk_assessment.v1`, `kye.assurance.model_validation.v1` unverified citation, `kye.assurance.audit_pilot.v1`, `kye.evidence.pack.v1` **engines**: `internal`, `internal`, `internal` **workers**: `kye-audit-pilot-agent`, `kye-conformance-runner`, `kye-evidence-pack-assembler` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.rc.software-classification` | Software-as-medical-device classification (MEDDEV / Rule 11) | enforced 1 unverified citation | **audit\_events**: `kye.risk_assessment.v1`, `kye.assurance.model_validation.v1` unverified citation **engines**: `internal`, `internal` **dictionaries**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-mdr-2002.rc.ai-saMD-classification` | AI-SaMD classification per Change Program alignment | enforced | **audit\_events**: `kye.risk_assessment.v1`, `kye.assurance.adoption_stage.v1` **engines**: `internal` **constitution\_refs**: `constitution/13-RESILIENCE-LOOP.md` |
| `mhra-mdr-2002.rc.intended-purpose-statement` | Intended Purpose Statement declared | enforced 1 unverified citation | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation **engines**: `internal` **governedui\_modules**: `kye.governedui.module.entity_passport.v1` **constitution\_refs**: `constitution/36-GOVERNEDUI.md` |
| `mhra-mdr-2002.rc.essential-requirements` | Essential requirements (safety, performance, info-supplied) | enforced 1 unverified citation | **audit\_events**: `kye.compliance.attestation.v1`, `kye.assurance.model_validation.v1` unverified citation **engines**: `internal` **workers**: `kye-compliance-card-refresh` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.rc.clinical-evaluation` | Clinical evaluation report | enforced 2 unverified citations | **audit\_events**: `kye.assurance.model_validation.v1` unverified citation, `kye.evidence.pack.v1`, `kye.evidence.healthcare.cdss.v1` unverified citation **engines**: `internal`, `internal` **workers**: `kye-evidence-pack-assembler` **sector\_packs**: `kye:sector-pack:healthcare` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |
| `mhra-mdr-2002.rc.technical-documentation` | Technical documentation (file kept by manufacturer) | enforced 1 unverified citation | **audit\_events**: `kye.evidence.pack.v1`, `kye.audit.event.appended.v1` unverified citation **engines**: `internal`, `internal` **workers**: `kye-evidence-pack-assembler`, `kye-audit-chain-worker` **constitution\_refs**: `constitution/30-AUDIT-WORM-RETENTION.md` |
| `mhra-mdr-2002.rc.UKCA-marking` | UKCA / UK Conformity-Assessment marking | designed 1 unverified citation | **audit\_events**: `kye.compliance.attestation.v1`, `kye.assurance.ato.v1` unverified citation **workers**: `kye-compliance-card-refresh` **constitution\_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.v1` **workers**: `kye-compliance-card-refresh` **constitution\_refs**: `constitution/21-DELEGATED-AUDITABILITY.md` |

Canonical KYE™ surfaces referenced on this page: [KYE Protocol™](https://kyeprotocol.com/) · [Purpose Permission](https://kyeprotocol.com/glossary/).