The European Union (EU) takes a significant step forward in regulating Artificial Intelligence (AI) with the introduction of the European Artificial Intelligence Act (AI Act). Simultaneously, DNV and the AI-Mind consortium are thrilled to announce upcoming webinar series on conformity management for medical device software that uses AI, touching upon both EU Regulation 2017/745 for Medical Devices (MDR) requirements and the AI Act.

The European AI Act represents a major milestone in the EU’s commitment to shaping the global AI landscape. Its key provisions include:

• Prohibition of AI systems that manipulate human behaviour.
• Strict rules for high-risk AI systems.
• Enhanced transparency and traceability.
• Independent conformity assessments.

In conjunction with this significant development, DNV and the AI-Mind consortium are co-organising a webinar series to shed light on relevant aspects of conformity management for medical device software that incorporates AI. Dr. Frédéric Courivaud, a medical device software expert from DNV’s Healthcare Research Programme will deliver three presentations on the most urgent topics, while Dr. Ira Haraldsen will introduce participants to the AI-Mind and explore how the project can benefit from Dr. Courivaud’s expertise.

Save the following dates for the webinar series:

• 6th June, 12:00-13:00 CEST: AI & Medical Device Software (MDSW): Views on specific conformity assessment aspects in the context of the current European regulatory landscape.
• 13th June, 12:00-13:00 CEST: Machine learning in medical device software: A Notified Body’s perspective in a changing regulatory landscape.
• 20th June, 12:00-13:00 CEST: Anticipating the AIA for the conformity assessment of medical device software.

Or register now: HTTPS://WWW.DNV.COM/RESEARCH/HEALTHCARE-PROGRAMME/AI-IN-MDSW.HTML#PREREGISTRATION 

The webinars target a diverse group of stakeholders interested in the intersection of AI and healthcare. This includes the AI-Mind consortium members, the Intervention Centre (IVS) network, clinicians, researchers, regulatory affairs professionals, medical device developers, hospital administrators, and IT support professionals. These meetings held in a hybrid format will provide a unique opportunity to gain valuable insights into the conformity management of medical device software and navigate attendees through the evolving landscape of AI regulation.

About the European Artificial Intelligence Act

The European Artificial Intelligence Act is a pioneering legislation introduced by the European Union to regulate the development and deployment of AI technologies. The Act aims to ensure the ethical and responsible use of AI while upholding fundamental rights and safety standards. It encompasses provisions for high-risk AI systems, transparency, and traceability requirements, as well as independent conformity assessments. The Act is a testament to the EU’s commitment to shaping the global AI landscape with a human-centric approach. To learn more about the European Artificial Intelligence Act and its implications, visit the official website at https://artificialintelligenceact.eu/.

About DNV

We are an independent expert in risk management and quality assurance. Driven by our purpose, to safeguard life, property and the environment, we empower our customers and their stakeholders with facts and reliable insights so that critical decisions can be made with confidence. As a trusted voice for many of the worlds most successful organisations, we use our knowledge to advance safety and performance, set industry benchmarks, and inspire and invent solutions to tackle global transformations.

DNV Product Assurance AS offers access for Medical device companies to the global market through approval to ISO 13485, MDSAP and Medical devices regulation (EU) 2017/745-MDR, through a global network of offices and personnel.

Contact: [email protected]