- Notified body association Team-NB has added to the criticism of the European Union's plans to regulate artificial intelligence, calling out an "overly broad definition" and the potential for duplicated requirements.
- Team-NB has come out strongly against multiple aspects of the proposal arguing that it will add to administrative burdens, reduce notified body capacity and create confusion without delivering benefits commensurate with the costs.
- The Team-NB intervention comes weeks after MedTech Europe called for urgent clarification of the planned AI regulation, again because of concerns about an overly broad definition and overlaps with existing regulatory frameworks.
The EU acknowledged the potential for the Artificial Intelligence Act (AIA) to overlap with existing regulatory frameworks when it proposed the regulation earlier this year. However, the EU sought to mitigate the problem by using existing conformity assessment procedures to check AI requirements, creating a model that a leading official said "would come to complement or to stand next to the MDR" to ensure that devices are "secure and trustworthy and so on."
Outsiders immediately pushed back against the proposals, with a computational statistician's early comment that the EU's AI definition "feels hopelessly vague" setting the tone for feedback from the medical device industry.
Team-NB picked up on some of the same points as other commenters, for example by highlighting what it sees as an overly broad definition of AI, but framed its feedback in the context of the impact of the proposals on notified bodies.
The association provided a lengthy opinion on the question, which is unanswered in AIA, of whether notified bodies will need accrediting against the AI regulation to take part in conformity assessment procedures. Team-NB is against having specific AIA accreditation.
"Additional accreditation of notified bodies against AIA would not bring more expertise, but just increase the administrative burden and by this reduce the already limited number of notified bodies and their capacity," the association wrote.
Instead, Team-NB wants the EU to expand the existing authorization framework, so a notified body designated under MDR or IVDR "would need to show competency for assessing AI related aspects." Team-NB wants the EU to avoid "having the AI part evaluated by an AI notified-body and the medical device part by an MDR/IVDR notified body ... to ensure that the special characteristic of medical devices and the general safety and performance requirements of a medical device are considered during the AI assessment."
Whatever the system, Team-NB warns attracting the AI experts needed for conformity assessments will be "the major challenge for all stakeholders." As Team-NB sees it, a "strenuous effort" is needed to build and attract experts, leading it to recommend a European AI initiative.