Earlier this year, the European Commission revealed its proposals to regulate AI, including medical devices and in-vitro diagnostics that use it. To be eligible for EU approval, high-risk AI systems must “comply with certain mandatory requirements” before they can be put on the market. They agreed that existing laws may be impacted, but saw their framework as complementing existing regulations like the Medical Devices Regulation.
MedTech Europe, on the other hand, believes that the plan falls short of that ambition. Medical technology companies in Europe, via their trade group, complained to the European Commission about apparent “misalignment” between MDR and IVDR, as well as with the Artificial Intelligence Act (AIA). According to MedTech Europe, the misalignments would have significant implications.
In a statement, MedTech Europe explained: “There are concerns that the AIA would in effect create the need for manufacturers to undertake duplicative certification/conformity assessment, via two Notified Bodies, and maintain two sets of technical documentation, should misalignments between AIA and MDR/IVDR not be resolved. Duplication of this kind would lead to unnecessary overlaps in the regulatory approval of AI as/in medical technology, which could have a negative effect on the timely access of citizens and patients to highly innovative and fairly priced AI medical technology in the EU.”
The feedback focuses on a few areas where MedTech Europe feels the rules are out of sync. A “very possible scenario” is what prompted MedTech Europe’s concerns regarding duplicative certification in its response. If a notified body that is designated for MDR or IVDR lacks AI capabilities, “the risk of needing two separate technical documentation submissions, leading to two separate conformity assessments and certifications, must be avoided.”
Clarification is also being requested on the designation of notified bodies for “AI-specific competencies”, the time required to ramp up the availability of notified bodies with AI and medtech capabilities, and the roles and responsibilities of notified bodies.
Additionally, the relationship between AIA and EU privacy regulations might cause issues. Several areas where AIA might clash with the General Data Protection Regulation (GDPR) were also highlighted by MedTech Europe. Examples include the AIA requirement that data sets used to develop high-risk AI systems be “relevant” and “representative”. Regulations like GDPR may make it tough for companies to comply with the law.
Risk classification is another perceived issue. As MedTech Europe sees it, AIA would put most healthcare uses of AI in its highest risk class in a “clear deviation from how medical technologies are regulated in Europe and around the world.” The deviation will cause confusion among regulators and “create additional, unnecessary complexity in the regulatory approval process,” the trade group wrote.
MedTech Europe’s expectation that medical devices and IVDs will fall into AIA’s high-risk category is underpinned by “the proposed broad definition of AI and risk classification.” The criticism of the definition follows an early response by a senior research scientist at the Flatiron Institute’s Center for Computational Mathematics, who said it “feels hopelessly vague with phrasing like ‘wide variety of methods’ and the inclusion of ‘statistical approaches’.”
Since then, the initiative has been attacked by other parties. It has been estimated that AIA may cost the EU economy up to €31bn over the next five years, and that investments might drop by as much as 20% as a result, according to the Center for Data Innovation By 2025, according to their research, AIA would cost European firms €10.9 billion a year. A business with a turnover of €10 million that deploys a high-risk AI system would see profits fall by 40%.
Other groups added onto the criticism, partly by noting that nothing that the AIA could “hinder the appetite for investment in Europe” according to Japan Business Federation, while Digital Poland Foundation argues that the definition is “too broad.”
But, some groups have been more receptive. Noted as “a good start” by an EU mapping trade group, and “ground-breaking legislation” according to a group working to guarantee the digital world caters to young people.
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