EU AI Act Notified Bodies: Who Can Certify High-Risk AI by 28 January 2028

Only 1 of the 8 Annex III areas can require an EU AI Act notified body, and that is biometrics. No page we opened names a single body designated for it. The bigger capacity question sits with product regulators, because existing sector bodies have until 28 January 2028 to apply. We could not extract a live NANDO count, so we show the evidence and the arithmetic instead.

Who can certify high-risk AI under the EU AI Act? A notified body designated by a member state and listed in the Commission's NANDO database, but only for systems that need one. That means certain biometric systems and AI inside products already subject to third-party assessment. Most other Annex III systems use internal control.

What NANDO evidence shows on EU AI Act notified bodies

The count should have been the easy part of this post, and we do not have it. NANDO is the Commission's database of notified bodies, and Article 35 requires the Commission to publish and maintain a list of bodies notified under the Act. On 6 November 2026 our automated reader received only an empty application page from NANDO, with no records, filters or legislation codes.

So we will not print a count by member state and scope as if we had extracted it. A number copied from someone else and presented as our measurement would break the only rule this publication exists to keep. What follows is the evidence we could open, graded by what each source actually claims.

The dated claims, side by side

Our reading is that the working assumption should be zero or close to it, and that you should check before relying on it. The check takes about 2 minutes in a normal browser: open NANDO, select legislation by Regulation 2024/1689, and read the list. If this post and NANDO disagree, NANDO wins.

Who can certify high-risk AI: the conformity routes by system type

The route depends on why a system is high-risk, and the sorting is more favourable to most software vendors than the compliance marketing implies. Article 43 of the AI Act creates a narrow third-party gate for stand-alone systems and hands product-embedded AI to the sector procedure that already exists.

Annex III point 1 is the narrow gate

Biometrics is the only stand-alone category where the Act can force a third party on a commercial provider. Article 43(1) requires Annex VII where the provider has not applied, or has applied only part of, the harmonised standard. The provider may choose any notified body. Choice only helps if a body exists to choose.

Points 2 to 8 do not need a queue

If you sell hiring, education or credit software, a vendor warning you about notified body waiting lists is selling the wrong fear. Article 43(2) states that internal control does not provide for the involvement of a notified body. Your burden is real, but it is documentation you own, which is a different planning problem from booking an auditor. How far compliance software automates that documentation is a separate question, and the answer varies by vendor.

Annex I products inherit an existing relationship

A product falls in here when it, or its AI safety component, is covered by listed legislation and is required to undergo third-party assessment under that law. That second condition is doing the work. Your existing medical device body is the natural first call, and it may not need to appear under Regulation 2024/1689 today to become your assessor later. We would not treat its silence on AI as a refusal until you have asked directly.

Why EN 18286 does not yet open the internal-control route

The first harmonised standard exists, but it does not cover what biometric providers need to escape Annex VII. EN 18286:2026 is the quality management standard, and the Commission describes it as designed for Article 17 requirements. AIActGuide reports it as the only harmonised standard cited as of 24 October 2026.

Article 43(1) turns on the Chapter III Section 2 requirements: risk management, data governance, record keeping, transparency, human oversight, accuracy and cybersecurity. The Commission requested standards across ten areas and names no other as published. Until those arrive, or common specifications replace them, AIActGuide's reading is that point 1 providers fall under Annex VII. We agree with that reading on the text.

The standard still matters for you. A quality management system is what a notified body examines under Annex VII, and it is required of internal-control providers too. Anyone who has run an ISO 42001 certification readiness programme will recognise the shape of the work. We have not verified how closely the two map, and you should not assume one certificate carries the other.

The 28 January 2028 deadline decides Annex I capacity

Annex I capacity will be set by whether existing sector bodies apply, not by how many new ones appear. Article 43(3) requires bodies notified under Annex I Section A legislation to apply for designation by 28 January 2028. That is about 18 months after the Omnibus entered into force on 27 July 2026.

The Omnibus also shortens the route. Articles 28(8) and 29(4) give those bodies a single application and a unified assessment, so they apply once rather than running a second parallel designation. This is the most useful change in the package for product makers, and it received far less attention than the headline delay.

There is also a legal reason the postponement should not be read as relief on capacity. Recital 40 justifies the delay by late standards, common specifications, guidance and national authorities. It does not name notified bodies. The delay bought time for the rulebook, and nothing in that recital promises that assessors will be staffed by the new dates.

AI Act conformity assessment capacity: a gap estimate with assumptions shown

No official demand or throughput figure exists in anything we could open, so the honest output is a sizing model rather than a finding. It answers one question: how many qualified assessor teams would the EU need by 2 August 2028 under plausible demand? Every input below is ours unless a source is named, and you should replace them with your own.

The assumptions, stated plainly

Time available. 635 days, or 1.74 years, from 6 November 2026 to 2 August 2028. This is generous, since no body can begin before it is designated.

Demand. We run 100, 300 and 600 assessments. The only public anchor is weak: at least 219 CE-marked AI medical devices as of January 2025, attributed to unnamed observers. Our 300 scenario is that floor plus 81 other systems, rounded by judgement. These are not market estimates.

Throughput. 3 assessments per team per year, implying 4 months each. Vendor pages claim between 2 and 6 months with no source, so we took a point inside that range and label it an assumption.

Bodies. 5, 15 and 50. The last is near the medical device pool, where vendor pages citing the Commission's December 2025 proposal put MDR designations at about 50. Being designated for devices does not mean having AI assessors.

The result: the team count does not move with the body count

Working: assessments divided by 1.74 years gives the annual rate. The annual rate divided by 3 assessments per team gives teams. Teams divided by bodies gives the last three columns. Results are rounded for display.

Our conclusion is that counting bodies is the wrong metric, and we would stop quoting it as a proxy for capacity. At 300 assessments, 5 bodies would each need 11.5 teams, while 50 bodies would each need about 1. The EU total stays near 57 either way, and the question is whether that many AI-qualified teams exist. That figure is absent from every source we read.

The medical device notified bodies' association has been worried for a while. A September 2025 summary of the Team-NB position reports difficulty ensuring enough notified bodies would be available. That is an interested party, and the view predates the Omnibus. It is still the people who would have to staff this saying they are concerned.

The biometric queue is where the capacity gap can bite first

If a shortage appears, it will appear in biometrics before it appears in medical devices. Providers there have an earlier date, 2 December 2027, and no incumbent sector body to return to. They also depend on bodies specifically notified under the AI Act, which is the list the last dated check found empty.

The arithmetic is small but unforgiving. Take 50 commercial biometric systems, which is our assumption and not a count, with 391 days available. At 3 assessments per team per year, that requires about 16 qualified teams from day one. Every month without a designated body raises the number.

Designation has its own lead time. Article 30(4) sets an objection window of two weeks with an accreditation certificate, or two months with documentary evidence, and that clock starts only after a national authority has finished its own assessment. Some member states were still building those authorities this year, which the count of member states with both enforcers named illustrates on a related duty.

Note who is outside this queue. Where law enforcement, immigration or asylum authorities, or EU institutions put the system into service, the market surveillance authority acts as the notified body. Vendors selling to those buyers should plan on a public authority conducting the assessment, with whatever capacity that authority has.

Where this argument is weakest

The largest weakness is the one in the second section: we did not read NANDO. Everything said about the current listing rests on a third-party check with no stated method, and a vendor post disagrees with it. A single designation published after 24 October 2026 would date our opening, though it would not change the routing or the sizing.

The demand side may be far smaller than our scenarios

Article 111(2) exempts systems placed on the market before the application date unless their design later changes significantly. That could remove most of the existing device base from our count, which is why our low scenario sits below the 219 floor. Sector bodies might also fold AI review into routine device assessment, in which case our separate team count overstates the need. A regulator could fairly call this model alarmist on both grounds.

Standards could arrive and shrink the biometric pool

If harmonised standards covering all Section 2 requirements are cited before December 2027, point 1 providers regain the internal-control option, and the third-party queue could fall sharply. The Commission page gives no dates for the remaining areas, so we cannot weigh this. Costs are equally unsettled: one essay we read gave both €5,000 to €50,000 and €50,000 to €150,000 for the same assessment, unsourced. We have left price out of the model rather than pick one.

Audit readiness for the AI Act: what to hold before you call a body

Audit readiness means being able to answer a body's first questions the day you find one, not having a slot booked. Work through the sequence below in order, because each answer can remove the need for the next. Enforcement is arriving through other channels meanwhile, as the AI Office's requests for information show, and the split of duties between model providers and downstream buyers may affect which documents you can obtain from suppliers.

• Write down your classification and its basis. Name the Annex III point or Annex I act, in one paragraph that a stranger could check.
• Record your route with the article number. Internal control under Article 43(2) is a defensible answer, and it ends the notified body discussion.
• Build the quality management system against Article 17. Every route needs it, and EN 18286:2026 now gives a presumption of conformity for what it covers.
• Keep a dated design-change log. Under Article 111(2), significant design change is what can pull an existing system into scope.
• Ask your sector body one written question. Will it apply under Article 43(3) by 28 January 2028, and with what AI scope?

Frequently asked questions

Where to start this week

Spend 30 minutes on a route memo. Write your system's Annex III point or Annex I act, the Article 43 paragraph that applies and the date that binds you. If the answer is Article 43(2), stop looking for a notified body and move that budget to your documentation.

If the answer is anything else, open NANDO in a browser, read the Regulation 2024/1689 list, and save a dated screenshot. Then send your sector body the single question from the list above, because a written answer in 2026 is worth more than any capacity estimate, including ours.

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