Understanding the AI Act roadmap
The European AI Act imposes a new framework on medical devices embedding artificial intelligence. Timeline, manufacturer challenges and certification hurdles: what you need to know to anticipate.
Manon Marault
The European AI Act imposes a new framework on medical devices embedding artificial intelligence. Timeline, manufacturer challenges and certification hurdles: what you need to know to anticipate.
As the countdown to CE marking under European Regulation 2017/745 on Medical Devices (MDR) continues, a new challenge is on the horizon with the implementation of the AI (Artificial Intelligence) Act.
AI Act timeline 📆
Based on the key information shared during the latest SNITEM symposium, which focused on the balance between innovation and regulation, here are the essential elements of the AI Act timeline:
• 𝐒𝐩𝐫𝐢𝐧𝐠 𝟐𝟎𝟐𝟑: Establishment of AI principles in healthcare at the European level.
• 𝐋𝐚𝐭𝐞 𝟐𝟎𝟐𝟑: Discussions for a political agreement to unify AI rules within medical devices.
• 𝟐𝟎𝟐𝟒-𝟐𝟎𝟐𝟕: Development of harmonised standards, designation of Notified Bodies (NB) for AI certification and enforcement of this new regulation.
It is important for medical device manufacturers to stay informed about the progress of the AI Act.
A new challenge for Notified Bodies 🧩
As this timeline advances, Notified Bodies must prepare to certify medical devices embedding AI. This adds a layer of complexity to the already tense MDR situation, potentially extending certification timelines for AI-embedded medical devices even further.
So how can you effectively anticipate to avoid a new bottleneck?
