In June 2023, the European Parliament adopted its position on the Artificial Intelligence Act (AI Act). Lawmakers have already started their negotiations to define the final text of the Act, which will become the first regulation on Artificial Intelligence. The final text could be published by the end of this year and could apply 24 months after entering into force. The implementation of the AI Act will impact regulatory requirements for a wide range of products and services, including medical devices and IVD medical devices.
MDR and IVDR regulatory framework for software
The Medical Devices Regulation (MDR) and In Vitro Medical Devices Regulation (IVDR) enact the regulatory framework for medical devices with software, including medical devices with AI embedded or AI system medical devices. In addition to the requirements applicable to all medical devices and in vitro diagnostic medical devices, some of the MDR and IVDR requirements for medical devices with software are:
- Manufacturers have to design their software to ensure repeatability, reliability, and performance in line with their intended use.
- In case the clinical evaluation is based on equivalent devices, the manufacturer must explicitly include the evaluation of the software algorithms.
- The software development must be done “in accordance with the state of the art taking into account the principles of development life cycle, risk management, including information security, verification and validation” (Annex I Article 2 MDR, and Annex I Article 16.1 IVDR).
Harmonised standards for AI medical devices
Under the MDR and IVDR, manufacturers can assess the conformity of their devices with the support of harmonised standards and common specifications. For medical devices embedding AI, manufacturers can apply the following standards:
- ISO 13485:2016 clause 4.1.6 on software validation
- IEC 62304 on life cycle requirements for medical device software
- IEC 62366-1 on usability engineering to medical devices
- ISO 14971 on risk management to medical devices, including software
- IEC 82304 on safety and security of health software products
Impact of AI Act on medical devices
According to the risk-approach classification of the new AI Regulation, the “high-risk” class entails any risk which can negatively affect safety or fundamental rights. This class is divided into two categories, with the first category grouping products that fall under the EU’s product safety legislation. Among different products, this category also includes medical devices and IVD medical devices.
The requirements set in the AI Act would apply to AI medical devices in addition to MDR and IVDR provisions. Under the proposed AI text, AI medical devices are classified as “high-risk” devices and require the intervention of a notified body that assesses the conformity of that device. The compliance of medical devices with AI systems has to be assessed together with the conformity assessment foreseen under the MDR or IVDR. Consequently, medical devices will be subject to a single conformity assessment under the MDR or IVDR, which must take into account the additional specific requirements set by the AI Act.
Furthermore, the AI Act foresees that market surveillance authorities must access confidential data and take corrective measures against non-compliant products. For non-compliance with AI-Act, the fines imposed would depend on the infringement’s severity and could reach up to 30 million euros or 6% of the annual turnover worldwide.
Our Library of Documents section dedicated to special categories includes all AI-related publications on medical devices.
European Parliament (2023) Artificial intelligence act. Retrieved on 14.09.2023.
Johner Institut (2023) Regulatorische Anforderungen an Medizinprodukte mit Machine Learning. Retrieved on 13.09.2023.
EUR-Lex (2017) Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC. Retrieved on 13.09.2023.
EUR-Lex (2017) Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU. Retrieved on 13.09.2023.