Artificial Intelligence (AI) in healthcare is already a reality. Healthcare providers have embedded the technology into their workflows and decision-making processes. The introduction of AI in healthcare has brought improvements for patients, providers, payers, other healthcare stakeholders, and society at large, also in the fight against the COVID-19 pandemic.

COCIR today published our first feedback to the Commission proposal for an Artificial Intelligence Act. It is essential to have a robust regulatory framework that provides certainty to all actors as new technologies are being developed and introduced into the market. Medical Device manufacturers have long-standing experience of operating in a highly regulated sector.

COCIR members take the responsibility towards end-users, especially patients, very seriously, to place safe and performing products on the European market. COCIR is a strong advocate of a targeted, sector-specific, and risk-based approach to the regulation of Artificial Intelligence.

We are looking forward to engaging with the EU institutions in the upcoming legislative process, together with our technical experts.