As of 1 November 2024, no centralised overview of available AI systems exists. The EU will establish a database of high-risk AI systems [23]. In addition, the EUDAMED database for medical devices is currently under development, but it will only provide a comprehensive overview once its use becomes mandatory [24]. This is expected to occur in 2026. The U.S. Food and Drug Administration's (FDA [25]) also maintains a public registry of medical devices with AI functionality, which may be a useful reference [26].
In the field of radiology, a dedicated website offers an overview of AI systems, including CE-marked systems including their classification and the applicable regulatory framework [27][28]. This site also provides additional documentation, such as peer-reviewed studies and information on FDA approvals.
As part of the early stages of procurement, it may be beneficial for the organisation to initiate an early market dialogue [29] to gain insight into available AI systems [30]. To verify regulatory compliance for medical devices, procurement teams should consider requesting key documentation from the manufacturer, such as the declaration of conformity, EC certificate, and instructions for use [31].
[23] The European Commission, in co-operation with the Member States, will establish a database for high-risk AI systems in accordance with Article 71 of the AI Act. The database will contain detailed information about the registered AI systems, including, among other things, the intended purpose, description of data used and the system's operational logic (Annex VIII of the AI Act).
[24] EUDAMED will consist of six modules related to: Operator Registration, Unique Device Identification (UDI) and Device Registration, Notified Bodies and Certificates, Clinical Investigations and Performance Studies, Vigilance and Market Surveillance. EUDAMED database (ec.europa.eu)
[27] AI for radiology database: Radiology (healthairegister.com)
[28] CE marking (standard.no) The marking means that the product is considered to fulfil the requirements of the authorities set out in a directive or regulation.
[29] RFI; request for information
[30] Request for information, a non-binding market survey to increase our own expertise about what the market offers and what we want to demand. Håndbok for planlegging og gjennomføring av tidlig markedsdialog i offentlige anskaffelser (PDF)
[31] A declaration of conformity for medical devices is a statement from the manufacturer that a medical device fulfils the requirements of the EU regulations for medical devices and thus receives a CE mark.