Notified Bodies Say Europe’s Artificial Intelligence Act Could Limit Access to Devices

The proposed European Artificial Intelligence Act (AIA) will impose an additional burden on the already limited number of notified bodies, resulting in delays in the marketing of new medical devices and technologies, the European Association of Medical Devices Notified Bodies (Team-NB) says.

The proposed legislation would require high risk medical devices and in vitro medical devices that include AI to undergo a conformity assessment by designated NBs. To become a designated NB for high risk devices, NBs must apply for approval in their Member State.

Team-NB argues that using the existing authorization framework to cover requirements outlined in AIA for medical devices would be more effective than updating the process.

The proposed legislation is already well-advanced and will become law once the European Council representing the 27 EU Member States and the European Parliament agree on a common version of the text.