IFU carries the serious-incident reporting notice (to the manufacturer and the Competent Authority) verbatim, without softened wording

Common NB finding · GSPR 23.4(z) · Art. 87 · see F9 · Evidence: IFU regulatory notice section

Intended purpose, indications, target population and contraindications on label / IFU match the CER and risk file word for word

Common NB finding · GSPR 23.4(b) · ISO 14971 · MDCG 2020-6 · see F1, I2 · Evidence: IFU section 1 vs CER vs risk management file

UDI carrier present in both AIDC (2D DataMatrix / linear barcode) and HRI form, with verified print grade ≥ 1.5 (C)

Common NB finding · Art. 27 · Annex VI Part C · ISO/IEC 15415 / 15416 · see A4 · Evidence: UDI master plan + barcode verification report

Reusable devices: maximum number of reuses, inspection / end-of-life criteria and validated reprocessing parameters stated in the IFU

Common NB finding · GSPR 23.4(n) · ISO 17664 / AAMI TIR12 · see F5 · Evidence: IFU reprocessing section + cleaning validation report

eIFU used only with Reg. (EU) 2021/2226 fulfilled: documented risk assessment, paper copy within 7 calendar days, access details on label

Common NB finding · GSPR 23.1(f) · Reg. (EU) 2021/2226 · see G1–G3 · Evidence: eIFU justification dossier + website SOP

CMR 1A/1B or endocrine-disrupting substances > 0.1% w/w (e.g. DEHP, DBP) labelled on device / packaging and explained in the IFU

Common NB finding · GSPR 10.4.5 · 23.2(f) · 23.4(s) · see D8 · Evidence: Material characterisation report (ISO 10993-18)

Every symbol not taken from EN ISO 15223-1 is fully explained in the IFU or accompanying documentation

Common NB finding · GSPR 23.1(h) · EN ISO 15223-1 · see C3 · Evidence: IFU symbol glossary vs master artwork

Regulatory route confirmed: device is under MDR 2017/745 (IVDs need a separate IVDR checklist, Annex I §20); class and rule recorded

Art. 51; Annex VIII · MDCG 2021-24 · Evidence: Classification rationale + regulatory strategy

Applicability of Annex I §23.1, 23.2, 23.3 and 23.4 mapped clause by clause, with a rationale for every N/A clause

Annex I §23 · Annex II §4 · Evidence: Labelling traceability matrix / GSPR checklist

TD contains the complete set of labels and IFUs: all packaging levels and all languages for the intended markets

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

Basic UDI-DI and UDI-DI assigned and UDI carrier requirements applied to every packaging level

Art. 27 · Annex VI Part C · Evidence: UDI assignment record + packaging hierarchy

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

Art. 29 · Annex VI Part A · Evidence: EUDAMED registration printout vs label

CE marking applied per Art. 20 and Annex V, with NB number where required, consistent with the DoC

Art. 20 · Annex V · Evidence: Label artwork + EU Declaration of Conformity

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

Art. 8 · MDCG 2021-5 Rev. 1 · Evidence: Standards list / gap assessment

EN ISO 15223-1:2021 + A1:2025 applied for symbols; current harmonised listing and transition arrangements checked

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

ISO 20417 edition confirmed (ISO 20417:2026 published March 2026); presumption of conformity claimed only for a harmonised EN edition

ISO 20417 · Evidence: Standards list + harmonisation status check

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

EN ISO 14971 · Evidence: Risk management file vs IFU

EN ISO 11607-1 / -2 applied to sterile barrier system labelling and packaging validation

EN ISO 11607-1 / -2 · Evidence: Packaging validation file

Sterilisation standard matches the declared method (EN ISO 11135 EO, EN ISO 11137 radiation, EN ISO 17665 moist heat)

EN ISO 11135 / 11137 / 17665 · Evidence: Sterilisation validation report vs label symbol

Product- or technology-specific standards applied for additional labelling, warnings and symbol requirements (e.g. IEC 60601-1, ISO 80369)

Device-specific standards · Evidence: Standards list + product-specific marking checks

Required particulars appear on the device itself, or a documented rationale shows direct marking is not practicable or appropriate

GSPR 23.1(b) · Evidence: Labelling traceability matrix + device drawing

Lay users: plain wording, legible type size, consult-a-professional circumstances stated, warnings validated in summative usability testing

GSPR 23.1(a) · 23.4(w) · IEC 62366-1 · Evidence: Usability engineering file + summative report

All symbols and identification colours conform to EN ISO 15223-1 (proportions, colours) or are described where no standard exists

GSPR 23.1(h) · Evidence: Artwork spec sheets + ISO 15223-1 alignment matrix

No IFU supplied (Class I / IIa): rationale shows safe use without instructions; 23.4(p) and (v) information available on request

GSPR 23.1(d) · Evidence: Risk management file + usability assessment

Label and IFU translated into the languages required by each target Member State, under a controlled translation procedure

Art. 10(11) · Evidence: Translation control procedure + language matrix

Label shows trade name, model / catalogue number, package contents, intended purpose where not obvious, and the MD symbol

GSPR 23.2(a), (b), (q) · Evidence: Master label artwork

Manufacturer legal name and registered address match the QMS / MDR certificate; EC REP name and address shown for non-EU manufacturers

GSPR 23.2(c), (d) · Evidence: Label drawing vs certificate + EC REP agreement

CE mark in correct proportions with the valid 4-digit NB number (Class Is, Im, Ir, IIa, IIb, III)

Art. 20 · Annex V · Evidence: Master label drawing + NB certificate

Lot or serial number shown with the ISO 15223-1 LOT / SN symbol; implantables carry serial (active) or serial / lot number

GSPR 23.2(g), (s) · Evidence: Packaging specification + batch record SOP

Use-by date unambiguous (at least year and month, YYYY-MM-DD or YYYY-MM) or date of manufacture where no use-by applies; matches aging data

GSPR 23.2(i), (j) · Evidence: Real-time and accelerated aging reports

Storage and handling conditions (temperature, humidity, light) listed and aligned with stability and transit testing

GSPR 23.2(k) · Evidence: Stability data + ASTM D4169 / ISTA transit report

Single-use device shows the do-not-reuse symbol and the IFU explains the risks of reuse, based on the risk file

GSPR 23.2(n) · 23.4(p) · Evidence: Packaging artwork + risk management file

Label indicates medicinal substances, human or animal tissues / derivatives, and qualitative composition for substance-based devices

GSPR 23.2(e), (r) · Evidence: Biological safety dossier + composition data

Sterile packaging recognisable as such; single or double sterile barrier symbol per EN ISO 11607-1

GSPR 23.3(a) · Evidence: Pouch / blister artwork + ISO 11607 file

Sterile state and method declared on the sterile barrier (STERILE EO, STERILE R, STERILE steam) and on the label

GSPR 23.2(l) · 23.3(b), (c) · Evidence: Primary packaging drawing + sterilisation validation

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

GSPR 23.3(j) · 23.4(l) · Evidence: Label artwork + IFU + risk controls

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

GSPR 23.3(d), (e), (h), (i) · Evidence: Primary label artwork + lot record SOP

IFU states intended purpose, indications, contraindications, patient target group, intended users and use environment

GSPR 23.4(b) · Evidence: IFU section 1 vs CER

Clinical benefits and performance characteristics match the CER and PMS data; Class III and implantables link to the SSCP in EUDAMED

GSPR 23.4(c), (d), (e) · Art. 32 · Evidence: CER clinical benefit analysis + SSCP

Residual risks, undesirable side-effects, warnings and precautions from the ISO 14971 file are fully listed

GSPR 23.4(g), (s) · Evidence: Residual risk table + IFU warnings section

Compatible devices, accessories and software / hardware versions, IT network and IT security requirements specified

GSPR 23.4(f), (q), (ab) · MDCG 2019-16 · Evidence: Cybersecurity file + system specification

Reusable devices: validated cleaning, disinfection and sterilisation parameters and end-of-life criteria stated

GSPR 23.4(n), (o) · Evidence: Cleaning and sterilisation validation (ISO 17664)

Installation check, preventive maintenance, consumables, calibration intervals and routine safety checks described

GSPR 23.4(k) · Evidence: Service and maintenance manual

Radiation-emitting devices: nature, type, intensity and distribution of radiation and protection measures stated

GSPR 23.4(r) · Evidence: IEC 60601-1-3 / IEC 60825 test report

Safe disposal of device, accessories and consumables: infection, sharps, WEEE and hazardous components covered

GSPR 23.4(v) · Evidence: Environmental risk assessment + IFU disposal section

IFU date of issue, or date and identifier of the latest revision, clearly shown

GSPR 23.4(y) · Evidence: Document history / revision table

Device and intended users qualify for eIFU under Reg. (EU) 2021/2226 (as amended)

Reg. (EU) 2021/2226 Art. 3 · GSPR 23.1(f) · Evidence: eIFU eligibility assessment

Documented eIFU risk assessment covers user access, failure modes and emergency information

Reg. (EU) 2021/2226 Art. 5 · Evidence: eIFU risk assessment

Paper IFU supplied free of charge within 7 calendar days on request; label shows eIFU symbol, website and how to request paper

Reg. (EU) 2021/2226 Art. 5–7 · Evidence: Website SOP + label artwork

Art. 18 applicability decided against the exempted device list (Art. 18(3)) and implant card device types

Art. 18(3) · MDCG 2021-11 · Evidence: Implant card applicability rationale

Implant card gives device name, type, serial / lot number, UDI, manufacturer name, address and website, with fields for patient, date and centre

Art. 18(1)(a) · MDCG 2019-8 · Evidence: Implant card artwork + verification check

Patient information covers expected lifetime, follow-up, warnings and precautions, and qualitative / quantitative material composition

Art. 18(1)(b)–(d) · GSPR 23.4(u), (aa) · Evidence: Patient information leaflet artwork

Card and leaflet state MRI status (MR Safe, MR Conditional, MR Unsafe) with verified conditions

Art. 18(1)(b) · ASTM F2503 · Evidence: MRI evaluation report (ASTM F2503 / ISO 10974)

Each warning, precaution and contraindication traces to a risk control or residual risk ID in the risk file

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

Claims and performance characteristics in label / IFU are supported by the CER and V&V data

Annex II §6 · MDCG 2020-13 · Evidence: CER + V&V summary

Label and IFU consistent with the DoC, EUDAMED data, SSCP and marketing material

Art. 19, 32 · Annex IV · Evidence: Cross-document consistency check

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

Annex III · Art. 83–86 · Evidence: PMS plan / PSUR + labelling change records

Legal MDR requirements, harmonised standards, 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 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, usability / systems engineer and medical safety / CER author

I3CGLOBAL control · Evidence: Signed QC approval record