Criteria for risk acceptability defined in the policy and RM plan, consistent with the state of the art and the MDR / IVDR requirement to reduce risks as far as possible (no economic or ALARP-only arguments)

Common NB finding · Annex I §2, §3 · EN ISO 14971 §4.2, §4.4 · Annex ZA / ZB · see B4 · Evidence: RM policy + RM plan acceptability matrix

Hazard identification is complete and systematic (all hazard categories, intended use and reasonably foreseeable misuse), not limited to an FMEA

Common NB finding · EN ISO 14971 §5.2–5.4 · ISO/TR 24971 Annex A · see C1–C4 · Evidence: Hazard list + PHA / FMEA / FTA

Probability and severity estimates justified with data sources (complaints, literature, test data, similar devices), not assumed; uncertainty and limitations of the estimates considered

Common NB finding · EN ISO 14971 §5.5 · see C7 · Evidence: Risk estimation rationale + data sources

Implementation AND effectiveness of every risk control measure verified, with reference to the V&V report

Common NB finding · EN ISO 14971 §7.2 · see D4 · Evidence: Risk control traceability to V&V reports

Information for safety is used only after design and protective measures; residual risks disclosed in IFU / label are traceable to the RMF

Common NB finding · Annex I §4 · EN ISO 14971 §7.1, §8 · see D2, H2 · Evidence: Risk control option analysis + IFU traceability

Overall residual risk and benefit-risk conclusion supported by the clinical evaluation (MDR) or performance evaluation (IVDR)

Common NB finding · Annex I §1, §8 · Art. 61 (MDR) / Art. 56 (IVDR) · see E3, E4 · Evidence: RM report vs CER / PER

PMS, complaints, vigilance, PMCF / PMPF and literature data fed back into the RMF, with RMF updated and dated accordingly

Common NB finding · Annex I §3(e), (f) · EN ISO 14971 §10 · see G1–G5 · Evidence: RMF revision history vs PMS / PSUR outputs

RMF is specific to this device, its intended purpose and its actual design and variants - not a generic or template file; hazards, estimates and controls reference this device's features, materials and data

Common NB finding · EN ISO 14971 §4.5, §5 · Annex II §1.1 · see C1, C3 · Evidence: RMF content vs device description and design documents

Risk management system established, implemented, documented and maintained as a continuous iterative process throughout the entire lifecycle

MDR / IVDR Annex I §3 · Art. 10(2) · EN ISO 14971 §4.1 · Evidence: RM procedure + RMF

RM procedure integrated in the QMS and applied to product realisation

EN ISO 13485 §7.1 · Art. 10 · Annex IX · Evidence: QMS procedure reference

Top management policy for establishing criteria for risk acceptability documented and approved

EN ISO 14971 §4.2 · Evidence: RM policy

Competence of persons performing RM tasks (incl. clinical / application expertise) documented

EN ISO 14971 §4.3 · Evidence: Training / qualification records

RM file structured and traceable for every identified hazard: analysis, evaluation, control, verification and residual risk

EN ISO 14971 §4.5 · Evidence: RMF index + traceability matrix

EN ISO 14971:2019 + A11:2021 applied, including Annex ZA (MDR) and Annex ZB (IVDR) relationship to the GSPRs; ISO/TR 24971:2020 used as guidance

Art. 8 · EN ISO 14971 Annex ZA / ZB · ISO/TR 24971 · Evidence: Standards list + GSPR checklist

TD Annex II §5 contains the benefit-risk analysis (Annex I §1 and §8) and the solutions adopted and results of risk management (Annex I §3)

Annex II §5 · Evidence: TD section 5 vs RMF and benefit-risk analysis

Risk-related Chapter I GSPRs mapped to the RMF: MDR Annex I §1–§5, §8 (and §9 for Annex XVI products); IVDR Annex I §1–§5, §8

MDR / IVDR Annex I Chapter I · Evidence: GSPR checklist rows vs RMF references

Supporting standards and guidance listed with editions: EN 62366-1:2015 + A1:2020, EN 62304:2006 + A1:2015, IEC 82304-1, MDCG 2019-16 Rev. 1, MDCG 2020-6 (MDR legacy) / MDCG 2022-2 (IVDR)

Art. 8 · MDCG register · Evidence: Standards and guidance list

Scope: device / device family, accessories, variants and configurations, intended purpose, intended users and use environment, and the lifecycle phases covered by the plan clearly defined; the plan is specific to this device, not a generic ISO 14971 template

EN ISO 14971 §4.4(a) · Evidence: RM plan

Responsibilities and authorities assigned

EN ISO 14971 §4.4(b) · Evidence: RM plan

Requirements for review of RM activities defined

EN ISO 14971 §4.4(c) · Evidence: RM plan

Criteria for risk acceptability and the methodology for estimating probability and severity defined and justified for this device, before individual risks are evaluated, based on the policy and including criteria where probability cannot be estimated; the risk matrix or other evaluation method is described with meaningful severity categories and consistently defined probability categories (a 5 × 5 matrix is not mandatory - the chosen method and its limitations are justified)

EN ISO 14971 §4.4(d) · Annex I §2 · Evidence: RM plan acceptability matrix

Method to evaluate overall residual risk and benefit-risk acceptability criteria defined in the plan before the clinical / performance evaluation

EN ISO 14971 §4.4(e) · ISO/TR 24971 §8 · Evidence: RM plan

Activities for verification of implementation and effectiveness of risk control measures defined

EN ISO 14971 §4.4(f) · Evidence: RM plan

Activities for collection and review of production and post-production information defined and linked to the PMS plan, with criteria for reviewing and updating the RMF

EN ISO 14971 §4.4(g) · Annex III · Evidence: RM plan vs PMS plan

Intended use and reasonably foreseeable misuse documented: intended purpose, indications and contraindications, patient population, intended users (incl. training / competence), use environment, operating principle and essential functions, accessories / compatible devices and interfaces, device lifetime and frequency of use, variants and configurations, and MDR / IVDR class - all consistent with the device description in the TD

EN ISO 14971 §5.2, §5.3 · EN 62366-1 · Annex II §1.1 · Evidence: RMF vs device description

Characteristics related to safety identified (e.g. ISO/TR 24971 Annex A questions answered)

EN ISO 14971 §5.3 · ISO/TR 24971 Annex A · Evidence: Safety characteristics list

Known and foreseeable hazards identified across all applicable categories (see the hazard category reference above) and all lifecycle phases, including manufacturing, transport, storage, use and disposal, with sequences of events leading to hazardous situations and harms

EN ISO 14971 §5.4 · ISO/TR 24971 Annex A · Evidence: Hazard list / PHA

Analysis method(s) defined in the plan, appropriate to the device and its complexity, and consistently applied (PHA, FMEA, FTA, HAZOP, use-related risk analysis); hazards, hazardous situations and harms clearly distinguished; ISO 14971 does not prescribe one universal method or matrix

EN ISO 14971 §5 · ISO/TR 24971 Annex B · Evidence: Analysis records

MDR: hazards from materials, biocompatibility, sterility, infection, energy, electrical / EMC, mechanical and combination with other devices addressed; implant-related risks for implantable devices and reprocessing risks for reusable devices included where relevant

MDR Annex I §10–§17 · EN ISO 10993-1 · IEC 60601-1 · Evidence: Hazard list vs GSPR checklist

IVDR: hazards from incorrect, invalid or delayed results analysed: false positive, false negative, invalid / indeterminate results and failure to produce a result, and their impact on clinical decisions, patients and public health; misleading or misinterpreted results considered even where the result is analytically valid

IVDR Annex I §1–§4 · ISO/TR 24971 Annex H · MDCG 2022-2 · Evidence: IVD result-error hazard analysis

Risk estimation: severity ratings justified; probability estimated and justified where feasible (criteria for non-estimable probability applied otherwise); data sources, assumptions, historical data, literature, testing and expert assessment documented

EN ISO 14971 §5.5 · Evidence: Risk estimation rationale

IVDR: pre-analytical, analytical and post-analytical hazards (sample stability, matrix interference, cross-reactivity, hook effect, carry-over, calibration, reagent stability, result reporting) and user infection / chemical exposure analysed

IVDR Annex I · ISO/TR 24971 Annex H · Evidence: IVD hazard analysis

Use-related hazards from the usability engineering process included: primary operating functions, use errors, perception / cognition / action hazards, user-interface mitigations

MDR / IVDR Annex I §5 · EN 62366-1:2015 + A1:2020 · Evidence: Use-related risk analysis vs usability file

Software hazards and software item contribution to hazardous situations analysed; IT security risks addressed

EN 62304 §7 · EN IEC 81001-5-1 · MDCG 2019-16 · Evidence: Software risk analysis + cybersecurity risk file

Risks from intended users and training assessed; lay users: incorrect use, misinterpretation of results and delayed medical action analysed

MDR Annex I §22 / IVDR Annex I §19 · Evidence: Lay-user risk analysis

Each estimated risk evaluated consistently against the acceptability criteria in the RM plan; unacceptable risks identified for further control; no blanket 'acceptable' ratings without criteria, rationale and evidence

EN ISO 14971 §6 · Evidence: Risk evaluation table

Risk control options applied in the mandatory priority order: inherently safe design and manufacture, protective measures (incl. alarms), information for safety and, where appropriate, training; warnings / IFU never used to avoid feasible design or protective measures, and any reliance on information for safety is justified

MDR / IVDR Annex I §4 · EN ISO 14971 §7.1 · Evidence: Risk control option analysis

Risks reduced as far as possible without adversely affecting the benefit-risk ratio; no economic argument used to stop risk reduction

MDR / IVDR Annex I §2 · EN ISO 14971 Annex ZA / ZB · Evidence: Risk control rationale

Each risk control measure clearly identified; implementation and effectiveness verified, with evidence traceable to the relevant test, analysis or inspection

EN ISO 14971 §7.2 · Evidence: V&V reports cross-referenced in RMF

Residual risk evaluated after controls for each hazardous situation

EN ISO 14971 §7.3 · Evidence: Residual risk table

Where residual risk is not acceptable, further controls applied or a benefit-risk analysis performed and documented; risks that remain unacceptable are addressed, not waived

EN ISO 14971 §7.4 · Evidence: Benefit-risk analysis

New hazards or increased risks introduced by risk control measures assessed and shown not to make risks unacceptable; residual risk reassessed after implementation

EN ISO 14971 §7.5 · Evidence: RMF review record

Completeness of risk control confirmed for all identified hazardous situations

EN ISO 14971 §7.6 · Evidence: Traceability matrix

Overall residual risk evaluated using the method and criteria in the RM plan, considering the contribution of all residual risks

EN ISO 14971 §8 · ISO/TR 24971 §8 · Evidence: RM report

Benefit-risk determination documented in the TD, with benefits linked to the intended purpose, severity and probability of harms considered, and uncertainties and limitations acknowledged; not based solely on an assertion of benefit

Annex II §5 · Annex I §1 · Evidence: Benefit-risk analysis

MDR: benefits and benefit-risk conclusion supported by clinical data in the CER; side-effects acceptable against benefits

MDR Art. 61 · Annex XIV · Annex I §8 · MEDDEV 2.7/1 Rev. 4 §9.3 / A7 · Evidence: CER benefit-risk section vs RMF

IVDR: benefits (clinical / analytical) and benefit-risk conclusion supported by the performance evaluation report

IVDR Art. 56 · Annex XIII · Annex I §8 · MDCG 2022-2 · Evidence: PER benefit-risk section vs RMF

Significant residual risks disclosed to users, with the information needed to do so included in the IFU / label

EN ISO 14971 §8 · Annex I §4 · Evidence: Residual risk disclosure list vs IFU

MDR: clinical benefits defined and quantified as patient-relevant outcomes (e.g. survival, symptom reduction, function) with measurable parameters

MDR Annex I §1, §8 · Art. 2(53) · Annex XIV · Evidence: CER clinical benefit definition

IVDR: benefits defined as diagnostic accuracy (sensitivity, specificity, PPV, NPV) and clinical utility / public health impact

IVDR Annex I §1, §8 · Annex XIII · MDCG 2022-2 · Evidence: PER clinical benefit definition

Benefit-risk benchmarked against the state of the art and alternative treatments / diagnostic methods; alternative risk controls considered where appropriate; conclusion consistent with the intended purpose, claims and IFU

MDR / IVDR Annex I §1 · MDCG 2020-6 · MEDDEV 2.7/1 Rev. 4 · Evidence: SOTA analysis in CER / PER

RM review performed before commercial release: plan implemented, overall residual risk acceptable, production / post-production methods in place

EN ISO 14971 §9 · Evidence: RM review record

RM report confirms completion of all planned activities, documents the required conclusions, addresses outstanding issues and limitations, and is reviewed and approved by the persons with assigned responsibility

EN ISO 14971 §9 · Evidence: Signed RM report

RMF revision, date and device version match the current TD revision and device configuration

QC consistency · Evidence: RMF document control vs TD index

RM report and RMF updated and re-approved when significant new information (PMS, vigilance, design or process changes) requires revision

EN ISO 14971 §9, §10.4 · Evidence: RMF / RM report revision history

System for collecting and reviewing production and post-production information (complaints, NC, CAPA, vigilance, literature, similar devices, state of the art) in place

EN ISO 14971 §10 · Annex III · Evidence: PMS procedure + PMS plan

MDR: PMS / PSUR (Art. 83–86) and PMCF outputs evaluated for impact on hazards, risk estimates and acceptability

MDR Art. 83–86 · Annex XIV Part B · Evidence: PSUR / PMS report vs RMF

IVDR: PMS / PSUR (Art. 78–81) and PMPF outputs evaluated for impact on hazards, risk estimates and acceptability

IVDR Art. 78–81 · Annex XIII Part B · Evidence: PSUR / PMS report vs RMF

Trend reporting, serious-incident data and relevant field safety corrective actions (own and similar devices) reviewed for new or increased risks

MDR Art. 87–88 / IVDR Art. 82–83 · Evidence: Vigilance and trend records

Design, manufacturing, supplier and labelling changes assessed for risk impact under change control; resulting RMF changes documented and approved

EN ISO 13485 §7.3.9 · EN ISO 14971 §10 · Evidence: Change control records

Each hazard traces to risk controls, verification evidence and residual risk acceptance

EN ISO 14971 §4.5 · Evidence: Traceability matrix

Warnings, precautions, contra-indications and limitations in IFU / label trace to residual risks

MDR Annex I §23 / IVDR Annex I §20 · Evidence: IFU vs residual risk table

GSPR checklist references the RMF for all applicable risk-related GSPRs

Annex II §4 · Evidence: GSPR checklist

RMF consistent with design inputs / outputs, design V&V reports, biological evaluation, sterilisation and packaging validation, and electrical safety / EMC testing, where applicable

Annex II §3, §6 · EN ISO 10993-1 · EN ISO 11607 · IEC 60601-1 · Evidence: Cross-document consistency check (design and testing)

RMF consistent with usability file, software V&V and cybersecurity documentation, PMS plan and PMS report / PSUR, and CAPA / complaint-handling records

EN 62366-1 · EN 62304 · MDCG 2019-16 · Annex III · Evidence: Cross-document consistency check (usability, software, PMS, CAPA)

Harms, side-effects and their frequencies consistent between RMF and CER / PER and SSCP / SSP

Art. 32 (MDR) / Art. 29 (IVDR) · Evidence: RMF vs CER / PER vs SSCP / SSP

Legal MDR / IVDR requirements, harmonised standards, non-binding guidance and internal I3CGLOBAL QC criteria kept separate

I3CGLOBAL control · Evidence: Reference register

Current harmonised standards list and latest MDCG revisions verified on the Commission website before final approval

MDCG register · OJEU · Evidence: Dated verification record

Each deficiency logged with corrective action, owner, target date and close-out sign-off

I3CGLOBAL control · Evidence: Deficiency and corrective action log

Final review signed by QA reviewer, RA specialist and clinical / performance evaluation expert

I3CGLOBAL control · Evidence: Signed QC approval record