28 July 2021

COCIR welcomes the opportunity to provide feedback to the European Commission’s inception impact assessment on adapting liability rules to the digital age and artificial intelligence.

Member organisations of COCIR have been at the forefront of bringing innovative health technologies, including Artificial Intelligence applications, to the market and to the patient. The Medical Device Regulation (MDR) and In-vitro Diagnostics Regulation (IVDR) establish a unique framework that takes a risk-based and lifecycle approach to the safety and performance of both medical hardware and software, even considering software in its own right. COCIR would like to refer to the recent study “Safety and Liability Related Aspects of Software” published by the European Commission which acknowledges the MDR/IVDR as one of the legal frameworks that is best suited to deal with software-related aspects. Moreover, this study clearly underlines that there are already regulatory frameworks in place that address particular challenges identified by the European Commission under the current initiative.

Introducing critical and lifesaving technology to the market COCIR fully embraces the principles – which are at the core of the healthcare sector - of safety, health and wellbeing for its users and patients. COCIR stands ready to work with the European Institutions, the Member States and relevant stakeholders and provide its longstanding expertise in the health technology space to ensuring liability rules are fit for the digital age.

Please see attached document for more details.