The European Commission (EC), the European authority in the sphere of medical devices, has proposed a new framework for the use of Artificial Intelligence technology in medical devices. The document is intended to introduce harmonized rules for AI-based medical devices allowed to be marketed and used in the European Union.
Regulatory Background
AI-based Products: General Approach
- There are certain regulatory gaps, so legal clarity is definitely needed.
- Overregulation is something to be avoided.
- The new framework should be neutral and balanced.
- A risk-based approach is optimal and acceptable for all the parties involved.
- Clear definitions of the most important terms, as well as detailed clarifications on the applicable risk-based classification rules in the context of AI systems, are required.
- Special regulatory sandboxes would allow to encourage further development of novel technologies and medical devices based thereon.
Additional Aspects
How Can RegDesk Help?
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Source: https://www.regdesk.co/european-commission-proposes-new-ai-medical-device-regulations/
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