How will the new EU AI Regulation affect conformity assessment for medical devices?

Question

The European Commission recently published a proposal for regulating AI systems. This regulation is not specific to medical devices but applies horizontally to all AI applications.

Key Points

• For high-risk AI systems related to products covered by the New Legislative Framework (NLF) legislation (such as medical devices), the AI requirements will be checked as part of the existing conformity assessment procedures under the relevant NLF legislation.
• It is unclear how this will apply to Class I medical devices, which do not require notified body (NB) involvement under MDR. There is a question whether high-risk AI in Class I devices would trigger NB involvement under the new regulation, potentially adding more bureaucracy.
• Manufacturers will still need to meet the requirements of the new AI law in addition to MDR, and auditors may need additional training or accreditation.
How will the new EU AI Regulation impact the conformity assessment process for medical devices, especially for Class I devices? Will high-risk AI components in Class I devices require involvement of a notified body under the new rules?

Dr. Oliver Eidel · Accepted Answer

According to the EU AI Regulation proposal, high-risk AI systems that are part of products already covered under the New Legislative Framework (like medical devices) are supposed to have their AI compliance checked within the existing conformity assessment routes. For most medical devices, this means the requirements for the AI system will be reviewed as part of the MDR process.
For Class I devices, it's less clear. The proposal mentions that where third-party assessment bodies aren’t currently required (as with most Class I devices), the regulation aims not to add extra assessment steps—unless the AI system itself is classified as high-risk. If your Class I device contains high-risk AI, it’s possible the new framework might require notified body involvement, even if MDR wouldn’t have required it. Basically, the AI regulation could add an extra layer of review for those devices.
We’ll have to wait for more detailed guidance to see exactly how this plays out, but at this stage, manufacturers of Class I devices with high-risk AI should be prepared for closer scrutiny and potentially new notified body requirements.

Answer

The regulation is designed to avoid duplication of conformity assessments, so high-risk AI in medical devices will usually be checked as part of the existing MDR process. For Class I devices, if there’s no notified body involved under MDR, my interpretation is that the new regulation could require a notified body to step in if the AI is considered high-risk. This isn’t confirmed yet, and we’ll need to see how the implementing acts clarify this.

How will the new EU AI Regulation affect conformity assessment for medical devices?

Key Points

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