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.

MHRA Medical Devices Regulations 2002: 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.

rule-9-active-therapeutic · enforced

Annex IX Rule 9 — Active therapeutic devices (energy delivery)
Audit events: kye.risk_assessment.v1, kye.compliance.attestation.v1 · Constitution: 29 profiles lite
rule-10-active-diagnostic · enforced

Annex IX Rule 10 — Active diagnostic devices
Audit events: kye.risk_assessment.v1, kye.compliance.attestation.v1 · Constitution: 29 profiles lite
rule-11-software-decisions · enforced

MDR Rule 11 — Software for decisions impacting therapy/diagnosis (covers most clinical SaMD)
Audit events: kye.risk_assessment.v1, kye.model.capability_profile.v1, kye.compliance.attestation.v1 · Constitution: 29 profiles lite
rule-15-IVD-disinfection · enforced

Annex IX Rule 15 — Devices for disinfection/cleaning of medical devices
Audit events: kye.risk_assessment.v1 · Constitution: 29 profiles lite
intended-purpose-binding · enforced

Intended purpose binding — class flows from declared intended purpose
Audit events: kye.model.capability_profile.v1, kye.purpose.permission.v1 · Constitution: 12 purpose permission
borderline-products · enforced

Borderline products (drug/device, software/lifestyle) — qualification decision
Audit events: kye.assurance.audit_pilot.v1, kye.evidence.decision_map.v1 · Constitution: 21 delegated auditability

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-mdr-2002/: On every framework page, after its opening.

Source: UK Statutory Instrument 2002/618 — Medical Devices Regulations 2002, as amended

By category

Category	Reqs	Enforced	Designed	Coverage
Classification Rules (Annex IX)	10	10	0	100%
Conformity Assessment (declaration / Approved Body / registration)	11	10	1	95%
Essential Requirements (Annex I, regs 7-12)	12	12	0	100%
Post-Market Vigilance (regs 44-47)	8	8	0	100%
Risk classes (Class I / IIa / IIb / III + software class)	12	10	2	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™ · Purpose Permission.

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