Retinal Screening Assistant
Support ophthalmology screening services by detecting referable diabetic retinopathy in colour fundus images and prioritising cases for specialist review.
- Status
- In operation
- State
- Deployed
- Owner
- Cirocco Jones
- Record completeness
- 0
100, less 12 for each open blocker and 4 for each warning. It measures the record, not the performance of the AI System.
The system is in operation while its record stands below the floor of 70. That contradiction is raised as blocker STATE-01.
- Blockers
- 14
EU AI Act
Only the articles this AI System's classification engages, filtered by the roles it holds. Monitored automatically while the Act applies.
High-risk (Annex I)
The system is a product, or the safety component of a product, covered by Annex I Union harmonisation legislation, and that legislation requires a third-party conformity assessment before market placement.
Article 6(1), Annex I section A · applies from 2 August 2027
The conformity assessment is not a second procedure. Article 43(3) puts the AI Act requirements into the assessment the sectoral notified body already performs.
Registration for an Annex I system is made in the non-public part of the EU database.
- Roles held
- Provider (Article 3(3))
- Fundamental rights impact assessment
- Not required
- EU database registration
- Required, Article 49
- Assessed against the text as at
- 2026-07-31
- Reference
- Not recorded
- Registered on
- Not recorded
- Registered as
- Not recorded
- Where it is done
- EU database for high-risk AI systems
The digital omnibus package of 19 November 2025 proposes targeted changes to the timing of some of these provisions. This assessment states the position under the regulation as adopted.
- 2 February 2025Prohibitions and AI literacyArticle 5 and Article 4 apply.
- 2 August 2025General purpose AI modelsChapter V applies, together with governance, notifying authorities and penalties.
- 2 August 2026The regulation generally, including Annex IIIHigh-risk systems listed in Annex III, and the Article 50 transparency duties.
- 2 August 2027Annex I embedded systemsHigh-risk systems that are, or are a safety component of, a product covered by Annex I harmonisation legislation.
- 2 August 2030Legacy systems in the public sectorArticle 111 for systems placed on the market before the general date of application.
Where the device is assessed by a notified body under the MDR, Article 43(3) places the assessment of the Act inside that route. The points below state how the two sets of requirements meet.
- One conformity assessment
The notified body already designated under the MDR carries out the AI Act assessment as part of the device assessment. There is no second body and no second certificate.
AI Act Article 43(3)
- One technical file
The Annex IV information is included in the MDR Annex II technical documentation rather than filed separately.
AI Act Article 11(2)
- One declaration of conformity
A single EU declaration of conformity covers both instruments, so a reader can see at once which law the device satisfies.
AI Act Article 47(3)
- One quality management system
The Article 17 quality management system is satisfied by the MDR Article 10(9) system, extended with the AI-specific elements rather than duplicated.
AI Act Article 17(4)
- One incident report
Serious incidents are reported through the MDR vigilance route. The AI Act does not add a second report for the same event.
AI Act Article 73(9)
- Pre-authorised change
Changes predetermined in the technical documentation and assessed by the notified body are not substantial modifications, so the PCCP mechanism carries into the Act.
AI Act Article 43(4)
- Annex IV, 1
General description of the AI system, its intended purpose and its versions.
MDR Annex II, 1.1 device description and specification
Held here as: AI System record, intended purpose, and the Use Cases
- Annex IV, 2(a)
Development methods, third-party tools, and the design specification.
MDR Annex II, 3 design and manufacturing information
Held here as: Models, model versions and the reproducibility records
- Annex IV, 2(d)
Datasets used, their provenance, scope, labelling and cleaning.
MDR Annex II, 6.1 clinical evaluation and data sources
Held here as: Datasets, dataset versions and dataset use and fitness
- Annex IV, 2(e)
Human oversight measures and the technical means enabling interpretation.
MDR Annex I, 5 and the instructions for use
Held here as: Controlled evolution, oversight plan and Use Case autonomy level
- Annex IV, 2(f)
Predetermined changes to the system and its performance.
MDR Article 120 change control and the PCCP where one is filed
Held here as: Controlled evolution and the PCCP
- Annex IV, 3
Monitoring, functioning and control, with accuracy metrics.
MDR Annex II, 6.2 performance evaluation
Held here as: Model version performance records and signals
- Annex IV, 5
Risk management system per Article 9.
MDR Annex I, 3 risk management system
Held here as: AI Risks, with their controls and their reviews
- Annex IV, 6
Changes made through the lifecycle.
MDR Annex II, 4 and the technical file revision history
Held here as: Planned modifications and the repository events
- Annex IV, 8
Post-market monitoring plan per Article 72.
MDR Annex III post-market surveillance plan
Held here as: Signals, reviews and the monitoring plan
- Annex IV, 9
EU declaration of conformity.
MDR Article 19 EU declaration of conformity
Held here as: External Documents, declaration of conformity
Clauses
Left, the clause list. Right, the clause you are working.
Ensure a sufficient level of AI literacy among the staff and others operating the system on your behalf.
Nothing is linked to Article 4. Link the Document record that addresses it and state how.
One reference for this clause. Link evidence already held, or register it here with its location or file.