"Medical Devices and the EU AI Act": manufacturers should pay attention to this now

The EU AI Act introduces strict requirements for AI-supported medical devices that affect risk management, data management and human oversight. Manufacturers are therefore forced to re-evaluate their market access strategies.

Our white paper "Medical Devices and the EU AI Act" will help you with this: we analyse how the new regulations will affect the industry and which strategic adjustments are now advisable for companies. We focus on the following aspects, among others:

• Manufacturers should keep an eye on and consider possible interactions of the EU AI Act with other directives, such as the U.S. Food and Drug Administration (FDA). At the same time, they should keep an eye on other emerging national and international AI regulations and also adapt to these standards.
• European authorities and international partners are working together to harmonise the interpretation and enforcement of various AI regulations. Nevertheless, uncertainties remain.
• We therefore recommend that manufacturers develop a new, comprehensive compliance strategy that takes all of these aspects into account. The main aim here is not to jeopardise the global distribution of their AI-supported medical innovations and to implement GxP-relevant requirements in new technologies in a compliant manner.  

Such a comprehensive compliance strategy is not only a valuable basis for minimising regulatory risks and acting responsibly in AI development. Rather, companies should take the opportunity to position themselves as pioneers in the global medical technology industry in the areas of safety, efficacy and ethical integrity.