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...
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...
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