How The EU’s AI Act Offers Regulatory Sandbox Solutions For Medtech Manufacturers

Are ‘regulatory sandboxes’ the answer to addressing complexities that will inevitably arise when the EU’s AI Act has been adopted and overlaps with the EU’s medtech regulations? This topic was examined by the European Commission at the recent International Medical Device Regulators Forum in Berlin.

Artificial Intelligence Concept
• Source: Alamy

The integration of AI and digital capabilities into medical technologies has made some medtech products so complex it is questionable in the EU whether the Medical Devices Regulation and the IVD Regulation are robust enough to accommodate all AI and digitally-enabled devices.

Key Takeaways 

The concept of regulatory sandboxes used in combination with the EU AI Act:

  • Could be useful in developing innovative products that do not readily into existing regulatory frameworks.
  • Will not offer a regulatory shortcut. Manufacturers who participate in regulatory sandboxes will still need to meet all the relevant requirements of the AI Act, the MDR and the IVDR

Moreover, the increasingly multilayered “regulatory lasagna” that impacts such products is causing EU regulators, notified bodies and manufacturers alike to scratch their heads as how to ensure products are in compliance with regulations that are sometimes overlapping, sometimes

More from Europe

More from Geography