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Mr Peep Peterson Minister of Social Affairs Ministry of Social Affairs Suur-Ameerika 1 10122 Tallinn Estonia Brussels, 25 November 2022 The Artificial Intelligence Act and its implications for medical devices Dear Minister Peterson, We would like to draw your attention to the ongoing legislative process on the proposed Artificial Intelligence Act (AI Act) and its implications for the medical technology sector regulated under the Medical Device Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR), which could implement a critical legislative change and a duplication of efforts. Artificial Intelligence (AI) is already a reality in healthcare. Healthcare providers have embedded these technologies in their workflows and decision-making processes12 via various applications in imaging, laboratories, patient monitoring, personalised apps, robotics, and many others without any indication that it has resulted in an increased number of safety issues. The medical technology industry is fully aware of its responsibility to place safe and efficient medical devices, whether AI enabled or not, on the market. In the EU, medical devices are comprehensively regulated by the MDR/IVDR. The MDR/IVDR contains a comprehensive set of requirements, such as risk management conformity assessments by notified bodies, post-market surveillance and vigilance systems, which have to be applied to AI-enabled medical device software.3 At the same time, it recognizes the broad variety and specific needs of the medical technology sector and ultimately ensures patient safety. We are deeply concerned about the expected impact of the proposed AI Act on the availability of medical device software and its interplay with the MDR and IVDR sectorial legislation, which as it stands will result in inconsistencies, duplications of requirements, legal uncertainty and increased costs. In particular: 1 https://www.cocir.org/activities/digital-health/artificial-intelligence-1/ai-use-cases.html 2 https://www.medtecheurope.org/resource-library/ai-in-medical-technologies/ 3 https://www.cocir.org/fileadmin/Publications_2021/COCIR_Analysis_on_AI_in_medical_Device_Legislation_-_May_2021.pdf  • The proposed AI Act introduces several definitions and concepts that would conflict with those established and required by the MDR/IVDR for years. For instance, the AI Act defines ‘provider’, ‘user’, ‘importer’, ‘putting into service’ differently than the MDR. • The proposed AI Act does not define the term ‘risk’. Even worse, the AI Act uses the term ‘risk’ in a different way than defined and used in the MDR/IVDR, and would require the implementation of a second risk management process in conflict with the risk management process required by the MDR/IVDR. • The requirements of the AI Act, like those of the MDR/IVDR, are intended to be supported by harmonised standards. Due to the horizontal nature of the AI Act, the horizontal standards requested for the AI Act would not be required to consider the sectorial specifics of the healthcare industry, which would result in standards incompatible with the existing and proven ones of the MDR /IVDR. • The proposed AI Act requires additional incident reporting channels and communication with different authorities than those required by MDR/IVDR. This would delay the time for the enforcement of resulting safety measures. Despite the enormous innovation capacity of the EU in the healthcare sector, we have already noted over recent years that other jurisdictions have become preferred locations to place innovative medical software on the market. We are concerned that the AI Act would add supplementary rules and complexity and would therefore accelerate this tendency. The result would not only be a threat to the competitiveness and innovation potential of the European healthcare industry at a global level, but eventually, lead to major disruptions in the access to innovative medical devices for EU citizens and their physicians, which ultimately is in opposition to the initial aims of the AI Act. In the interest of European patients and healthcare systems, we call for a legislation that is fully consistent with MDR/IVDR and leaves no room for interpretation by, for example, Notified Bodies or market surveillance authorities. This is essential to guarantee the continued availability of AI-enabled medical technology on the European market, based on rules that are set by the AI Act and the MDR/IVDR complementing each other. COCIR and MedTech Europe are committed to be trusted and collaborative partners in the policy discussion on the responsible application of AI in healthcare. Yours sincerely, Annabel Seebohm Serge Bernasconi Secretary General Chief Executive Officer COCIR MedTech Europe Saatja: Philipp Goedecker <[email protected]> Saadetud: 25.11.2022 16:46 Adressaat: SM Info <[email protected]> Koopia: Annabel Seebohm <[email protected]>; <[email protected]> Teema: [COCIR] COCIR and MedTech Europe Letter on Artificial Intelligence Act Dear Minister Peterson, COCIR and MedTech Europe would like to bring to your attention their views and recommendations regarding the ongoing legislative process on the proposed Artificial Intelligence Act (AI Act) and its implications for the medical technology sector. Please find them in the attached co- signed letter by COCIR Secretary General Annabel Seebohm and MedTech Europe Chief Executive Officer Serge Bernasconi. COCIR is the European Trade Association representing the medical imaging, radiotherapy, health ICT and electromedical industries and is unique as it brings together the healthcare, IT and telecommunications industries. MedTech Europe is the European Trade Association for the medical technology industry including diagnostics, medical devices and digital health. Their members are national, European and multinational companies as well as a network of national medical technology associations who research, develop, manufacture, distribute and supply health-related technologies, services and solutions. Thank you in advance for the consideration. Yours sincerely, Philipp Goedecker Digital Health Senior Manager COCIR Diamant Building - 80 Bd A. Reyers - B-1030 BRUSSELS Tel.: &#43;32 (0) 2 706 89 63 - Mob.: &#43;49 (0) 152 5475 3027