Notified Bodies and AI Medical Devices Under the EU AI Act

For high-risk medical AI, you do not appoint a separate "AI Act notified body":

• Under Article 43(3), the notified body from your MDR/IVDR route also checks your AI Act conformity, as part of the same assessment.
• A notified body may do this only once it has been assessed for that scope under the notification procedure (Article 43(3) points to the requirements in Article 31).
• Whether you need a notified body at all is decided by your MDR/IVDR class (Class IIa+ or the special Class I subtypes; IVDR B/C/D or sterile A). Basic self-certified devices have no notified body step.
• Confirm your notified body's AI Act scope early. Capacity is already tight in medtech, and AI Act designation is an added dimension.

Every legal claim below is cited. See Sources.

Why this matters

Notified-body capacity has been one of the hardest bottlenecks of the MDR transition. Layering AI Act conformity onto the same bodies raises an obvious practical question: is your notified body equipped to assess the AI Act parts, and when. Getting ahead of that, rather than discovering it late in your conformity timeline, is the difference between a smooth CE process and a stalled one.

Do you even need a notified body?

That is the same question as "am I high-risk". A notified body is required when your device is MDR Class IIa, IIb or III, or the special Class I subtypes (sterile, measuring, reusable surgical), or IVDR Class B, C, D or sterile A. If a notified body is involved and your device contains AI, you are high-risk (see Is my medical AI high-risk?). Basic self-certified devices (MDR Class I, IVDR Class A) have no notified body, and are not high-risk via Article 6(1).

How the AI Act uses your notified body (Article 43(3))

The AI Act was designed to plug into the medical-device route rather than run a parallel one. Article 43(3) states that, for high-risk AI covered by the MDR/IVDR, the provider follows the conformity assessment procedure required under those acts, and the AI Act's high-risk requirements are assessed as part of that procedure. It then adds that notified bodies already notified under the MDR/IVDR are entitled to control the conformity of the AI system with the AI Act requirements, provided their compliance with certain requirements in Article 31 (paragraphs 4, 5, 10 and 11) has been assessed in the notification procedure.

In plain terms: it is your existing notified body, doing the AI Act check inside your existing assessment, but only once it has been signed off for that scope. You are not shopping for a second body; you are confirming your current one is designated for the AI Act dimension.

What to confirm with your notified body

• Is it designated for your AI Act scope, or on track to be, for your device type.
• How the AI Act elements fold into your technical documentation review (data governance, logging, human oversight, accuracy and robustness), rather than as a separate submission. The crosswalk maps these obligations to what you already hold.
• Timelines and capacity, so the AI Act dimension does not become the gating item in your CE schedule.

A note on timing (this is moving)

Scope and dates for AI in medical devices are being revised through the Digital Omnibus proposed in November 2025, which would defer application dates and reduce duplication between the AI Act and the MDR. Treat specific dates as provisional; the mechanism in Article 43(3), your notified body doing an integrated check, is the durable part. Our deadlines tracker follows the detail.

Do I need a special AI Act notified body?

No. Under Article 43(3), the notified body from your MDR or IVDR conformity assessment also checks the AI Act requirements, as part of the same procedure, once it has been assessed for that scope. You do not appoint a separate body.

What if my notified body is not designated for the AI Act yet?

That is the practical risk to manage. The body must have been assessed against the relevant Article 31 requirements before it can control AI Act conformity. Confirm your body's scope and timeline early so it does not become the bottleneck in your CE process.

My device is Class I and self-certified. Is there a notified body step?

No. Basic self-certified devices (MDR Class I, IVDR Class A) have no notified body, and are not high-risk via Article 6(1). Transparency obligations under Article 50 can still apply if the product interacts with patients.

Sources (official)

• EU AI Act, Regulation (EU) 2024/1689: per-article on the European Commission AI Act Service Desk. Cited: Article 43(3) (integrated conformity; notified bodies notified under the MDR/IVDR may control AI Act conformity, subject to Article 31), Article 6 (high-risk trigger), Article 50 (transparency); official text on EUR-Lex.
• MDR / IVDR, Regulations (EU) 2017/745 and 2017/746: Article 52 (MDR) and Article 48 (IVDR) determine notified-body involvement by class.

Legalithm provides compliance information and tooling, not legal advice. Notified-body scope and availability depend on your device and body; confirm directly with your notified body and qualified counsel. Article references are to Regulation (EU) 2024/1689 (the AI Act).