In a post published on the association’s blog and signed by Alexander Olbrechts, director Digital Health, MedTech Europe turned the spotlight back on the possible impact of the AI Act, the new European legislation that aims to regulate the safety and quality aspects of artificial intelligence applications. An area that is presented to offer numerous opportunities in the field of medical technologies as well, side by side with just as many challenges in how to implement them.
First and foremost is the need to integrate the new provisions of the AI Act with what is provided by existing industry legislation, most notably the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR). MedTech Europe’s goal here is to continue the dialogue with European legislators to ensure that the two strands of legislation actually complement each other, avoiding duplication of activities or conflict with procedures already in place.
One of the main goals of the AI Act, moreover, is to arrive at a smoothly flowing compliance process for AI-enabled medical technologies. A goal that, according to Olbrecht, should involve aligning compliance assessment with what is already in place in the MDR and IVDR regulations. The suggestion here is to maintain the existing technology codes for notifications to authorities and notified bodies, to which is added the possibility of assisting sectoral notified bodies with designation procedures under the AI Act, avoiding delays.
The MDR and IVDR regulations also introduced a strong component of clinical investigations and studies on device performance to support their efficacy and safety. According to Medtech Europe, the AI Act should serve as a facilitator in this regard, and a specific priority clause should be provided for the MDR and IVDR regulations in case of conflict with the provisions of the new AI legislation. MedTech Europe’s request is that it be definitively clarified that clinical and performance evaluations should be considered exempt from any requirement for CE certification under the AI Act, and thus continue to follow the pre-market testing rationale established of two medical device and in vitro diagnostic regulations.
Finally, there is no shortage of mention of the development of new digital therapies, in which AI models and data analytics play a key role in the development, for example, of innovative diagnostic solutions that can reduce the need for hospitalization.