MedTech Europe responds to the public consultation on an EU legal act for Artificial Intelligence

Posted on 10.09.2020

Artificial Intelligence (AI) in medical technologies has the potential to deliver on the promise for better healthcare in Europe. To optimise the value of AI in the healthcare sector, policies need to remain flexible and follow the evolution of technological development, allowing space for technology to thrive both within big and smaller companies.

Therefore, we at MedTech Europe, are keen to bring today our healthcare expertise and perspective to the AI policy conversation via our response to the public consultation on an EU legal act for Artificial Intelligence.

We much welcome the aim of the European Commission (EC) to address many legal and ethical issues, raised by AI, to foster the developments and uptake of AI, and to avoid legal fragmentation across Member States. We agree that European citizens need to be confident that their medical technologies, with or without an AI component, provide a high level of safety and quality for patients. In the medtech sector, the safety and effectiveness of medical device software, including "AI with an intended medical purpose", is already addressed through existing, recently reinforced, regulations, i.e. Medical Device Regulation (EU) 2017/745 ("MDR") and in vitro diagnostics Regulation (EU) 2017/746 ("IVDR").

It is for this reason that MedTech Europe supports the idea that, while assessing the need for new legislation specific to AI, the application of existing regulations on AI should be taken into account to understand whether any gaps exist and to avoid overlap and conflicting regulations that could cause issues when AI is introduced.

Please read our full response here and our general position on Artificial Intelligence here.