MedTech Europe (MTE), the European trade association representing the medical technology industry including diagnostics, medical devices and digital health, has provided its response to the European Commission’s adoption consultation on the proposed Artificial Intelligence Act (AIA).
The Association comments that: “Artificial Intelligence (AI) technology is increasingly used in healthcare and in recent years has been greatly enhancing the workflows and decision-making processes of healthcare providers. The medical technology industry would like to stress the importance of a robust regulatory framework, which provides legal coherence, certainty, and clarity to all actors. In particular, interpretation issues of the new rules for AI that comprises, or is incorporated in, medical technology, should be addressed.”
In this respect, MTE states: “We call for particular attention to be paid to misalignment between provisions in the AI Act and the Medical Device Regulation (MDR) and In-Vitro Diagnostics Regulation (IVDR) as well as the General Data Protection Regulation (GDPR). Addressing this misalignment is essential to ensure the legal coherence, certainty and clarity needed to foster innovation, citizen access to quality care and competitiveness of industry.”
MTE points out that the proposed broad definition of AI and risk classification will result in all medical device software falling within the scope of the AI Act as a high-risk AI system, since most medical device software needs a conformity assessment by a Notified Body.
“Duplication and potential conflicts arising from misalignment between the AIA and existing obligations under MDR/IVDR must be avoided in order to ensure legal coherence, certainty and clarity,” continues MTE. Obligations in the AIA are thematically similar to the requirements in MDR/IVDR but differ in terms of detail, which may lead to complex interpretation issues. There are therefore 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” claims MTE.
Copies of the full MTE response can be obtained from here.