IFU intended purpose covers every IVDR element: what is detected or measured (analyte / marker), function (screening, diagnosis, monitoring, prognosis, prediction, companion diagnostic), condition, specimen type, testing population, intended user, automated or not, qualitative / semi-quantitative / quantitative

Common NB finding · Annex I §20.4.1(c) · Annex II §1.1 · see G1 · Evidence: IFU intended purpose vs TD device description and PER

Analytical and clinical performance claims in the IFU match the performance evaluation report exactly; no claim without supporting data

Common NB finding · Art. 56 · Annex XIII · see J4–J8 · Evidence: IFU performance section vs PER (scientific validity, APR, CPR)

Electronic IFU used only for devices intended for professional use, never for self-testing or near-patient testing (Reg. (EU) 2021/2226 is an MDR regulation and does not apply to IVDs)

Common NB finding · Annex I §20.1(f) · see C5 · Evidence: eIFU rationale vs intended user

Self-testing / near-patient testing: label and IFU wording validated with representative intended users; result reading and follow-up actions are understood

Common NB finding · Annex I §19, §20.4.2 · IEC 62366-1 · see M1 · Evidence: Usability / lay-user comprehension study report

Reagents containing dangerous substances or mixtures carry CLP pictograms, signal words and hazard / precautionary statements; SDS available unless all information is in the IFU

Common NB finding · Annex I §20.1(i), (j) · Reg. (EC) 1272/2008 · Reg. (EC) 1907/2006 · see D12 · Evidence: CLP classification + SDS vs label artwork

Metrological traceability of calibrator and trueness-control values stated, with reference materials / reference measurement procedures of higher order

Common NB finding · Annex I §20.4.1 · EN ISO 17511 · see G4 · Evidence: Traceability report vs IFU

IFU carries the serious-incident reporting notice (to the manufacturer and the Competent Authority of the Member State where the user and/or patient is established)

Common NB finding · Annex I §20.4.1 · Art. 82 · see K5 · Evidence: IFU regulatory notice section

Device qualifies as an IVD under Art. 2(2); risk class (A, B, C, D) and classification rule recorded with rationale

Art. 2(2) · Art. 47 · Annex VIII · MDCG 2020-16 · Evidence: Qualification and classification rationale

Applicability of Annex I §20.1, 20.2, 20.3, 20.4.1 and 20.4.2 mapped clause by clause, with a rationale for every N/A clause

Annex I §20 · Annex II §4 · Evidence: Labelling traceability matrix / GSPR checklist

TD contains the complete set of labels and IFUs: outer, inner and primary container labels, all kit components and all languages for the intended markets

Annex II §2 · Evidence: TD labelling section + artwork index

Basic UDI-DI and UDI-DI assigned; UDI carrier applied on the label and on all higher packaging levels

Art. 24 · Annex VI Part C · Evidence: UDI assignment record + packaging hierarchy

Manufacturer and device data on the label (name, SRN, address, Basic UDI-DI) match the EUDAMED registration

Art. 26–28 · Annex VI Part A · Evidence: EUDAMED registration printout vs label

CE marking applied per Art. 18 and Annex V, with NB number for Class B, C, D and Class A sterile; consistent with the EU DoC

Art. 17, 18 · Annex IV, V · Evidence: Label artwork + EU Declaration of Conformity

Standards list identifies each labelling standard with edition and IVDR harmonisation status; approach to standards follows MDCG 2021-5

Art. 8 · MDCG 2021-5 · Evidence: Standards list / gap assessment

EN ISO 18113-1 (terms, definitions and general requirements) applied; current edition and harmonisation status checked

EN ISO 18113-1 · Evidence: Standards list + labelling compliance matrix

Reagents: EN ISO 18113-2 (professional use) or EN ISO 18113-4 (self-testing) applied as relevant

EN ISO 18113-2 / -4 · Evidence: Reagent label and IFU compliance matrix

Instruments: EN ISO 18113-3 (professional use) or EN ISO 18113-5 (self-testing) applied as relevant

EN ISO 18113-3 / -5 · Evidence: Instrument label and IFU compliance matrix

EN ISO 15223-1 applied for symbols, including the IVD symbol; current edition, amendments and harmonised listing checked

EN ISO 15223-1 · Evidence: Symbol alignment matrix + OJEU listing check

EN ISO 14971 used to cross-check warnings, precautions, limitations and residual risks

EN ISO 14971 · Evidence: Risk management file vs IFU

Instrument / software standards applied for markings and IFU content (e.g. EN IEC 61010-1 and -2-101, EN IEC 61326-2-6, EN 62304, EN IEC 82304-1)

Device-specific standards · Evidence: Standards list + test reports

Class D: applicable common specifications (Reg. (EU) 2022/1107) checked for performance and labelling-related requirements

Art. 9 · Reg. (EU) 2022/1107 · Evidence: CS compliance matrix

Medium, format, content, legibility and location suit the device, its intended purpose and the intended user's knowledge; drawings / diagrams used where helpful

Annex I §20.1(a) · Evidence: Label and IFU artwork review

Required particulars appear on the device itself or, where not practicable (e.g. small vials), on the packaging for each unit (primary / inner) and on the outer packaging

Annex I §20.1(b) · Evidence: Labelling traceability matrix + packaging hierarchy

Label is human-readable; machine-readable forms (barcode, RFID) only supplement it

Annex I §20.1(c) · Evidence: Label artwork

No IFU / abbreviated IFU only in duly justified, exceptional cases where safe and intended use without an IFU is demonstrated

Annex I §20.1(d) · Evidence: Justification + risk management file

IFU supplied in paper by default; electronic IFU only for professional-use devices (not near-patient testing), with label stating how to access it

Annex I §20.1(f) · §20.2 · Evidence: IFU delivery rationale + label artwork

Self-testing and near-patient testing devices: IFU supplied in paper (hard copy) with each device

Annex I §20.1(f) · Evidence: Packaging content list + IFU

Single IFU copy for multiple devices to one user / location only where agreed with the purchaser; further copies free on request

Annex I §20.1(e) · Evidence: Distribution SOP / purchaser agreement

Residual risks to be communicated are included as limitations, contra-indications, precautions or warnings

Annex I §20.1(g) · Evidence: Residual risk table vs IFU

Symbols from EN ISO 15223-1 used; any symbol or identification colour not covered by a harmonised standard or CS is described in the documentation supplied

Annex I §20.1(h) · Evidence: IFU symbol glossary vs master artwork

Label and IFU in the official Union language(s) required by each target Member State, under a controlled translation procedure

Art. 10(10) · Evidence: Translation control procedure + language matrix

Device name / trade name and catalogue, model or reference number; intended purpose where not obvious

Annex I §20.2(a), (b) · Evidence: Master label artwork

Legal manufacturer name / registered trade name or trade mark and registered place of business

Annex I §20.2(c) · Evidence: Label vs certificate / EUDAMED

EC REP name and address shown for manufacturers based outside the EU

Annex I §20.2(d) · Evidence: Label + authorised representative mandate

Clear IVD designation: statement "In vitro diagnostic medical device" or the IVD symbol (EN ISO 15223-1); or, where applicable, device for performance study

Annex I §20.2(e) · Evidence: Label artwork

Total kit contents indicated: volume, weight, number of tests or items included

Annex I §20.2(j) · Evidence: Label artwork vs kit configuration

Lot number (LOT) or serial number (SN) shown with the ISO 15223-1 symbol

Annex I §20.2(f) · Evidence: Label artwork + batch record SOP

UDI carrier present in both AIDC (linear / 2D barcode) and HRI form with verified print quality

Annex I §20.2(g) · Art. 24 · Annex VI · ISO/IEC 15415 / 15416 · Evidence: UDI plan + barcode verification report

Use-by date unambiguous (YYYY-MM-DD or YYYY-MM) and supported by real-time stability data; date of manufacture where no use-by applies

Annex I §20.2(h), (i) · EN ISO 23640 · Evidence: Stability report vs label

Storage and handling conditions (temperature limits, humidity, light, other) shown and aligned with stability and transport studies

Annex I §20.2(k) · Evidence: Stability + transport study reports

Sterile status and sterilisation method declared if supplied sterile, or any special microbial state / cleanliness

Annex I §20.2(l) · Evidence: Label artwork + validation report

In-use / open-vial stability (after opening, reconstitution, thawing or preparation) shown where different from shelf life, or referenced to the IFU

Annex I §20.2(k) · EN ISO 18113-2 · Evidence: Label artwork + in-use stability data

Full CLP alignment for hazardous chemicals, preservatives (e.g. sodium azide) or biological hazards: GHS pictograms, signal word, hazard (H) and precautionary (P) statements (detail in IFU where space is insufficient)

Annex I §20.1(i) · Reg. (EC) 1272/2008 · Evidence: CLP classification vs label

Disclosure where reagents contain material of human or animal origin, including infectious agents or biological control sera (biological risk warning)

Annex I §20.2(m) · §20.4.1 · EN ISO 18113-2 · Evidence: Label artwork + material origin records

Other warnings / precautions needing the user's immediate attention shown, kept to a minimum with detail in the IFU

Annex I §20.2(m) · Evidence: Label artwork vs risk file

Self-testing or near-patient testing use stated explicitly on the label

Annex I §20.2 · Evidence: Label artwork

Single-use indication where applicable; kit components also sold separately are labelled as devices in their own right

Annex I §20.2 · Evidence: Label artwork + kit component list

Primary container shows component name and volume / quantity

Annex I §20.1(b) · EN ISO 18113-2 / -4 · Evidence: Primary label artwork

Primary container shows lot (LOT) or serial (SN) number

Annex I §20.2(f) · EN ISO 18113-2 / -4 · Evidence: Primary label artwork

Primary container shows an unambiguous use-by date

Annex I §20.2(h) · EN ISO 18113-2 / -4 · Evidence: Primary label artwork

Primary container shows storage conditions (or symbol)

Annex I §20.2(k) · EN ISO 18113-2 / -4 · Evidence: Primary label artwork

Component identity clear: reagent / active ingredient, buffer, calibrator or control material (with level where relevant); hazard information where required

EN ISO 18113-2 / -4 · Reg. (EC) 1272/2008 · Evidence: Primary label artwork vs kit composition

Sterile packaging identified as such, with a declaration of sterile condition and the sterilisation method

Annex I §20.3 · Evidence: Primary packaging artwork + sterilisation validation

Sterile packaging shows manufacturer name and address, device description, month and year of manufacture and use-by date

Annex I §20.3 · Evidence: Primary label artwork

Instruction to check the IFU if the sterile packaging is damaged or unintentionally opened; IFU gives the action to take

Annex I §20.3 · §20.4.1 · Evidence: Label artwork + IFU

Sterile barrier system and sterilisation method consistent with validation (EN ISO 11607-1/-2, EN ISO 11135 / 11137)

EN ISO 11607 · EN ISO 11135 / 11137 · Evidence: Packaging and sterilisation validation reports

Intended purpose stated in full: analyte / marker / parameter, qualitative, semi-quantitative or quantitative, clinical indication and function (screening, confirmatory, monitoring, diagnosis, CDx), patient population and intended user (laboratory professional, trained healthcare worker or lay person)

Annex I §20.4.1(c) · Evidence: IFU vs TD Annex II §1.1 and PER

Companion diagnostics: INN of the associated medicinal product stated

Annex I §20.4.1(c) · Art. 48 · Evidence: IFU + medicinal product SmPC reference

Test principle described: scientific principle, reaction or detection method (e.g. PCR, ELISA, lateral flow)

Annex I §20.4.1 · Evidence: IFU text

Metrological traceability of calibrator and control values to reference materials / higher-order reference measurement procedures

Annex I §20.4.1 · EN ISO 17511 · Evidence: Traceability report

Reagent composition: nature and quantity, proportion or concentration of active ingredients, with buffers and other components

Annex I §20.4.1 · EN ISO 18113-2 / -4 · Evidence: Kit composition / formulation record vs IFU

Materials provided vs materials required but not provided (ancillary equipment, reagents, consumables) listed completely

Annex I §20.4.1 · Evidence: IFU vs kit configuration

Preparation and storage: reconstitution, thawing, mixing, dilution; validated in-use and working-solution stability stated (e.g. stable 30 days at 2–8 °C after opening)

Annex I §20.4.1 · EN ISO 23640 · Evidence: In-use stability reports vs IFU

Specimen type(s) stated (e.g. serum, EDTA plasma, nasal swab, capillary whole blood)

Annex I §20.4.1(c) · Evidence: IFU vs specimen validation data

Pre-analytical requirements: patient preparation, collection tube types, anticoagulant compatibility, centrifugation speed / time, transport, storage temperature, specimen stability and allowable freeze–thaw cycles

Annex I §20.4.1 · Evidence: Specimen stability study vs IFU

Step-by-step procedure: sample dilution, incubation times / temperatures, washing, read-out window

Annex I §20.4.1 · Evidence: IFU procedure section vs V&V protocols

Calibration procedure, calibration frequency and zero / blank setting described

Annex I §20.4.1 · Evidence: IFU calibration section

Internal and external QC procedures, acceptance criteria and actions when a control fails stated

Annex I §20.4.1 · Evidence: IFU QC section

Compatible instruments, devices and general-purpose equipment identified, with any known restrictions on combinations

Annex I §20.4.1 · Evidence: Compatibility / interoperability data

Criteria for reading results: cut-off values, thresholds, positive / negative / indeterminate (invalid) decision points; whether confirmatory testing is needed

Annex I §20.4.1 · Evidence: IFU results section vs PER

Mathematical approach / calculation for quantitative results described

Annex I §20.4.1 · Evidence: IFU calculation section

Biological reference intervals for defined populations stated where relevant

Annex I §20.4.1 · Evidence: Reference interval study

Limit of blank, limit of detection and limit of quantitation stated

Annex I §20.4.1 · Annex XIII Part A · Evidence: Analytical performance report

Analytical specificity, cross-reactivity and endogenous / exogenous interferents (haemolysis, icterus, lipaemia, common drugs) stated

Annex I §20.4.1 · Annex XIII Part A · Evidence: Interference / cross-reactivity study

Measuring interval and linearity stated

Annex I §20.4.1 · Annex XIII Part A · Evidence: Linearity study

Precision stated: repeatability (within-run) and reproducibility (between-day / lot / site / operator); trueness and accuracy where relevant

Annex I §20.4.1 · Annex XIII Part A · Evidence: Precision study

Clinical performance: diagnostic sensitivity and specificity, PPV and NPV where relevant, consistent with the CPR

Annex I §20.4.1 · Annex XIII · MDCG 2022-2 · Evidence: Clinical performance report vs IFU

Procedural limitations stated: interfering substances (HIL), hook / prozone effect limits, false-positive and false-negative scenarios, specimen limitations and populations in which the assay is not validated

Annex I §20.4.1 · Evidence: IFU limitations section vs risk file

Warnings and precautions: signs of malfunction or degradation, external influences, infectious or hazardous materials, sensitising substances; special facilities or training where relevant

Annex I §20.4.1 · Evidence: Risk file vs IFU warnings section

Safe handling, biological decontamination and waste disposal (biohazard waste, sharps, CLP-classified chemicals; infection, environmental and physical hazards)

Annex I §20.4.1 · Evidence: IFU disposal section

Class C and D: IFU references the location of, and link to, the Summary of Safety and Performance on EUDAMED

Art. 29 · MDCG 2022-9 · Evidence: IFU text vs SSP

Serious-incident reporting notice to the manufacturer and the Competent Authority

Annex I §20.4.1 · Art. 82 · Evidence: IFU regulatory notice

IFU date of issue / revision date and version number, with modifications clearly indicated; manufacturer contact for technical assistance

Annex I §20.4.1 · Evidence: IFU footer / revision history

Intended platform role, compatible assays and automated steps performed (e.g. extraction, amplification, detection)

Annex I §20.4.1(c), (i) · Evidence: Instrument IFU vs assay menu / compatibility list

Measurement principle described: optical detection system, thermal cycling, fluidics path, sensor mechanics

Annex I §20.4.1 · EN ISO 18113-3 / -5 · Evidence: Instrument IFU vs design description

Instrument performance stated: precision across runs / wells / positions, carry-over limits, photometric / fluorescence linearity

Annex I §20.4.1 · EN ISO 18113-3 / -5 · Evidence: Instrument V&V reports vs IFU

Clinical performance cross-referenced to the assay-specific IFUs / application sheets

Annex I §20.4.1 · Evidence: Instrument IFU cross-references

Sample handling: rack types, dead-volume requirements, accepted tube types and dimension tolerances

Annex I §20.4.1 · Evidence: Instrument IFU vs V&V data

Electrical safety and EMC disclosures: ratings, voltage, frequency, power consumption, fuse ratings; declarations aligned with EN IEC 61010-1, EN IEC 61010-2-101 and EN IEC 61326-2-6

Annex I §20.4.1 · EN IEC 61010-1 / -2-101 · EN IEC 61326-2-6 · Evidence: Instrument manual + rating plate vs safety / EMC test reports

Ambient operating limits: temperature, humidity, altitude and ambient light

Annex I §20.4.1 · EN IEC 61010-1 · Evidence: Instrument IFU vs environmental test data

Installation verification and readiness checks described

Annex I §20.4.1 · Evidence: Installation / IQ instructions

Interoperability: compatible LIS protocols (e.g. HL7, ASTM / CLSI LIS2), middleware specification, minimum hardware, operating system and IT network requirements

Annex I §20.4.1 · Evidence: System specification + interface documentation

Data security / cybersecurity measures, including protection against unauthorised access

Annex I §20.4.1 · MDCG 2019-16 · Evidence: Cybersecurity file

Consumables and reagent compatibility: qualified reagents, wash solutions, cuvettes and calibration consumables required for valid results clearly specified

Annex I §20.4.1 · Evidence: Compatibility list vs V&V data

Calibration: protocol and frequency, factory calibration standards, optical / performance verification tools and start-up self-test diagnostics

Annex I §20.4.1 · EN ISO 17511 · Evidence: User manual calibration section + factory calibration records

Maintenance: daily / periodic intervals, user-serviceable vs manufacturer-serviceable parts, consumable replacement

Annex I §20.4.1 · Evidence: Service / user manual

Cleaning and decontamination procedures, including decontamination before service, and biohazard spill management

Annex I §20.4.1 · EN IEC 61010-2-101 · Evidence: User manual cleaning / decontamination section

Error / fault messages and diagnostic codes listed with corrective actions

Annex I §20.4.1 · Evidence: User manual troubleshooting section

Label and IFU legible and understandable for the intended user, confirmed by usability testing

Annex I §19 · IEC 62366-1 · Evidence: Usability engineering file + summative report

Illustrated step-by-step instructions in simple, non-clinical language: reagent preparation, specimen collection, running the test, reading the result

Annex I §20.4.2 · Evidence: IFU procedure section + usability data

Visual guide (photos / drawings) for positive, negative and invalid results; results presented so they are readily understood

Annex I §20.4.2 · Evidence: IFU results section

Advice on action for positive, negative and indeterminate results; test limitations; possibility of false positive / false negative; factors that may affect the result

Annex I §20.4.2 · Evidence: IFU interpretation section

Self-testing: prominent statement not to take any medical decision or adjust medication without consulting a healthcare professional; information on the disease, its prevalence and national advice sources where available

Annex I §20.4.2 · Evidence: IFU text

Self-testing for monitoring a diagnosed condition: patient adapts treatment only after appropriate training

Annex I §20.4.2 · Evidence: IFU text

Self-testing: instructions for safe disposal of used and contaminated components at home (lancets, swabs, cassettes, buffer)

Annex I §20.4.1 · §20.4.2 · Evidence: IFU disposal section

Near-patient testing: prominent, fast-action warnings and internal / external QC routines suitable for non-laboratory clinical staff (nurses, clinic staff)

Annex I §19 · §20.4.1 · §20.4.2 · Evidence: IFU warnings and QC section + usability data

Each warning, precaution, limitation and contra-indication traces to a risk control or residual risk in the risk file

EN ISO 14971 · Annex II §5 · Evidence: Labelling-to-risk traceability matrix

Claims in label / IFU supported by the PER (scientific validity, analytical and clinical performance)

Art. 56 · Annex XIII · Evidence: PER vs IFU claims

Class C and D: Summary of Safety and Performance consistent with the IFU and written for the intended user (and patient where relevant)

Art. 29 · Evidence: SSP vs IFU

Label and IFU consistent with the DoC, EUDAMED data and marketing material; no misleading claims

Art. 7 · Art. 17 · Evidence: Cross-document consistency check

PMS, PMPF, vigilance and FSCA outputs reviewed for labelling impact; label / IFU changes under change control

Art. 78–81 · Annex III · Evidence: PMS plan / PSUR + labelling change records

Class C and D self-testing: SSP includes a dedicated summary written in language a lay person can understand

Art. 29 · MDCG 2022-9 · Evidence: SSP lay-person section

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

I3CGLOBAL control · Evidence: Reference register

Not every standard or guidance applied to every device: applicability and exclusion rationale recorded

I3CGLOBAL control · Evidence: Reference register / applicability notes

Controlled reference register shows title, identifier, edition, publication date, applicability, harmonisation status, link and date last checked

I3CGLOBAL control · Evidence: Reference register

Current IVDR harmonised standards list, common specifications 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, usability / systems engineer and performance evaluation expert

I3CGLOBAL control · Evidence: Signed QC approval record