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Initial rule catalogue · EU MDR · software display · version 2026-10-19.1
Information supplied means a presence or syntax check passed. It does not mean the label complies with the law.
Coverage and limits
- This initial catalogue checks selected information and syntax. It does not establish compliance, classification, identifier assignment or release approval.
- Language, legibility, symbol conditions, IFU adequacy, CE/conformity assessment, direct marking, packaging hierarchy and specialist-device requirements still need review.
- Custom-made, investigational, performance-study, no-UI software, reagents/kits and other special contexts are not fully modeled. Exception claims are never automatically accepted.
Device contextApplicability unknown
The declared context selects this partial catalogue. Special statuses and incompatible device/surface choices require review; no classification or exemption is inferred.
Regulation (EU) 2017/745, Annex I 23
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.scope
- deviceKind:
- unknown
- marketStatus:
- unknown
- labelLevel:
- software-display
Selected label surfaceInformation supplied
Select the surface in the project. This does not establish which levels are legally required or justify omitted levels.
Regulation (EU) 2017/745, Annex I 23
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.surface
- selectedSurfaces:
- software-display
- evaluatedSurface:
- software-display
Device identityInformation supplied
Checks that a device name was supplied; identity accuracy requires review.
Regulation (EU) 2017/745, Annex I 23.2(a)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.identity
- deviceName:
- DermaScan AI
Manufacturer name and addressInformation supplied
Checks presence of the entered legal manufacturer and registered business address, not their correctness.
Regulation (EU) 2017/745, Annex I 23.2(c)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.manufacturer
- manufacturerName:
- Example Manufacturer
- manufacturerAddress:
- Example address
EU authorised representativeApplicability unknown
A manufacturer established outside the Union needs its authorised representative's name and registered address. Establishment is user-declared.
Regulation (EU) 2017/745, Annex I 23.2(d)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.representative
- manufacturerRegion:
- unknown
- authorisedRepName:
- Not entered
- authorisedRepAddress:
- Not entered
Intended purpose on the labelApplicability unknown
Intended purpose is required where it is not obvious to the user; this checks the declared applicability and presence only.
Regulation (EU) 2017/745, Annex I 23.2(b)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.purpose
- purposeObvious:
- unknown
- intendedPurpose:
- Medical device software that supports the assessment of skin images.
Production identificationApplicability unknown
Supply the appropriate lot or serial identifier; suitability and traceability require review.
Regulation (EU) 2017/745, Annex I 23.2(g)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.production
- deviceKind:
- unknown
- softwareVersion:
- 3.4.1
- lotNumber:
- Not entered
- serialNumber:
- Not entered
Safe-use time limitApplicability unknown
Where a safe-use time limit applies, supply it. This editor accepts complete real YYYY-MM-DD dates; it does not determine shelf life.
Regulation (EU) 2017/745, Annex I 23.2(i)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.expiry
- hasExpiry:
- unknown
- expiryDate:
- Not entered
Manufacture date when no safe-use limitApplicability unknown
When no safe-use time limit is indicated, supply the manufacture date. Clearly identifiable dates within lot/serial codes require manual review; this check expects a separate date.
Regulation (EU) 2017/745, Annex I 23.2(j)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.manufacture-date
- hasExpiry:
- unknown
- manufactureDate:
- 2026-07-19
Special storage or handlingApplicability unknown
Special storage/handling conditions are conditional on the device; content adequacy is not assessed.
Regulation (EU) 2017/745, Annex I 23.2(k)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.storage
- specialStorage:
- unknown
- storageConditions:
- Not entered
Sterile state and methodApplicability unknown
If supplied sterile, state the sterile condition and method. Other microbial/cleanliness claims and packaging requirements need review.
Regulation (EU) 2017/745, Annex I 23.2(l)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.sterility
- sterile:
- unknown
- sterilizationMethod:
- Not entered
Single-use indicationApplicability unknown
Single-use indication is conditional. Confirm the intended reuse status and applicable wording/symbol; this catalogue does not validate reprocessing claims.
Regulation (EU) 2017/745, Annex I 23.2(n)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.single-use
- singleUse:
- unknown
Warnings and precautionsReview required
Risk-derived warnings and their prominence need professional review; supplying text is not evidence that all required warnings are covered.
Regulation (EU) 2017/745, Annex I 23.2(m)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.warnings
- warning:
- Consult the electronic instructions for use before use.
Medical-device and special-status indicationReview required
Confirm medical-device, custom-made and investigational indications against the device's actual regulatory status.
Regulation (EU) 2017/745, Annex I 23.2(p, q)
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.device-indication
- deviceKind:
- unknown
- marketStatus:
- unknown
Software UDI placementApplicability unknown
Standalone device software uses readable plain text UDI on an accessible/startup screen; AIDC is not required on electronic displays. No-UI software requires API transmission and remains outside this renderer.
Regulation (EU) 2017/745, Annex VI Part C 6.5.4
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.software-carrier
- deviceKind:
- unknown
- labelLevel:
- software-display
UDI applicability and exceptionsApplicability unknown
Confirm UDI applicability, implementation timing and any special-device exceptions. The declared required status is not an authority determination.
Regulation (EU) 2017/745, Article 27; Annex VI Part C
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.udi-applicability
- udiApplicability:
- unknown
- udiExceptionRationale:
- Not entered
- deviceClass:
- Not entered
Requirements outside automated checksReview required
This initial catalogue checks selected information and syntax. It does not establish compliance, classification, identifier assignment or release approval. Language, legibility, symbol conditions, IFU adequacy, CE/conformity assessment, direct marking, packaging hierarchy and specialist-device requirements still need review. Custom-made, investigational, performance-study, no-UI software, reagents/kits and other special contexts are not fully modeled. Exception claims are never automatically accepted.
Regulation (EU) 2017/745, Annex I 23
Consolidated 2026-07-19 · source checked 2026-10-19 · rule eu-mdr.coverage
- deviceClass:
- Not entered
- eifuUrl:
- https://ifu.example.test/dermascan