The Artificial Intelligence Regulation Proposal: A Team-NB critique

The Artificial Intelligence Regulation Proposal: A Team-NB critique

On October 6, 2021, Team-NB (the EU Medical Devices - Notified Body Association) published a position paper on the recently published European Artificial Intelligence Regulation proposal. In addition, it also means to analyse possible overlaps with the existing EU legislation on medical devices, i.e., Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR).

The Paper focuses on specific key topics, such as the definition of artificial intelligence (AI) systems, the inclusion of medical devices in the AI Regulation, vigilance reporting, conformity assessment procedures, and notified body accreditation.

Concerning the definition of AI system found in Article 3(1) and Annex I, Team-NB finds it to be “overly broad” and that it could cause confusion for regulators, manufacturers, and notified bodies (Team-NB, 2021). They further recommend the use of the definition included in the international standard ISO/IEC 2382:2015 Information technology - Vocabulary.

Sector-specific requirements set out by the New Legislative Framework (NLF) already cover many products that incorporate AI. For example, medical devices are regulated under the MDR and fall under the scope of the AI Regulation as high-risk AI systems (cfr. Title III of the Proposal). According to Team-NB, this leads to “defragmentation” and “work duplication”, “both of which serve to increase the costs, and impair the implementation efficiency”. Furthermore, Team-NB (2021) recommends “developing industry specific guidance for implementation of the AI regulation together with existing NLF framework addressing risk category, state of the art, testing & assessment requirements”.

Regarding vigilance reporting, Team-NB recommends avoiding developing a parallel line of communication with the authorities, which is already in place under the MDR and IVDR. A conformity assessment procedure that requires parallel documentation would also be unnecessary. Moreover, the Paper calls for a European AI Initiative to tackle the challenge from a broader perspective, namely, to face the lack of technical expertise

Finally, the Position paper covers the accreditation of notified bodies. Team-NB does not hide once again their concern regarding parallel accreditation for the assessment of NLF (e.g., medical device) and AI parts of the product, as this would cause further administrative burdens without necessarily bringing more regulatory expertise.

Get in touch

Tancredi Vergani

RA Department

23 November 2021


References:

Team NB (2021). Team-NB Position Paper. European Artificial Intelligence Regulation. Retrieved on r 23/11/2021 from https://www.team-nb.org/wp-content/uploads/2021/10/Team-NB-PositionPaper-Artificial-Intelligence.pdf

European Commission (2021). Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING DOWN HARMONISED RULES ON ARTIFICIAL INTELLIGENCE (ARTIFICIAL INTELLIGENCE ACT) AND AMENDING CERTAIN UNION LEGISLATIVE ACTS. COM/2021/206 final. Retrieved on 23/11/2021 from https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:52021PC0206&from=EN