In short
- Article 43(2) of Regulation (EU) 2024/1689 routes Annex III points 2 to 8 through internal control under Annex VI, with no third party involved.
- Only Annex III point 1, biometrics, can require a notified body under Annex VII, and only where harmonised standards were not applied or do not cover the requirements.
- Systems that are safety components of products in Annex I follow the conformity assessment of the product legislation instead, under Article 43(3).
- A substantial modification triggers a fresh assessment under Article 43(4), but predetermined learning changes recorded in the technical documentation do not count as one.
- The route matters for scheduling: Annex III duties apply from 2 December 2027 and Annex I duties from 2 August 2028.
The phrase most likely to derail a compliance plan is that a high-risk system needs certification. Most of them do not.
Article 43 of Regulation (EU) 2024/1689 sends the large majority of standalone high-risk systems through internal control, a procedure the provider runs itself. Knowing which route applies changes the budget, the schedule and the people involved.
01What are the two routes in Article 43?
Annex VI, run internally, and Annex VII, run with a notified body.
| System | Procedure | Provision |
|---|---|---|
| Annex III points 2 to 8 | Internal control, Annex VI | Article 43(2) |
| Annex III point 1, standards applied | Provider chooses Annex VI or VII | Article 43(1) |
| Annex III point 1, standards not applied | Notified body, Annex VII | Article 43(1) |
| Annex I Section A product | The product legislation procedure | Article 43(3) |
Internal control is not a lighter obligation. It is the same set of requirements in Chapter III Section 2, assessed by the provider instead of by an outside body, and it still ends in a declaration of conformity under Article 47 and a CE marking under Article 48.
What changes is who is convinced. Under Annex VI the audience is a market surveillance authority reading your file after the fact, which is a slower and less forgiving reader than an assessor you can talk to.
02Why is biometrics treated differently?
Because the harm is identification, and the error is invisible to the person it happens to.
Annex III point 1 covers remote biometric identification, biometric categorisation and emotion recognition. Article 43(1) is the only place in the standalone regime where a third party can be compulsory, and the trigger is the absence of harmonised standards or common specifications rather than the sensitivity of the use.
That link between standards and route is worth holding onto. A harmonised standard published for these systems converts a mandatory notified body assessment into a choice, which is why standardisation work changes compliance cost more than most amendments do.
For law enforcement, migration and Union institution uses of these systems, Article 43(1) makes the relevant market surveillance authority act as the notified body, so the assessment does not disappear, it changes hands.
03What happens if the system sits in an Annex I product?
It follows the product’s own law, and the AI requirements are folded in.
Article 43(3) applies where the high-risk system is a safety component of a product covered by the Union harmonisation legislation listed in Annex I Section A, such as machinery or medical devices. The provider runs the conformity assessment that legislation already requires, and the Chapter III Section 2 requirements become part of it. Regulation (EU) 2026/1744 amended Article 43(3) so that notified bodies designated under that product legislation can assess the AI requirements too, provided they apply for designation under the AI Act by 28 January 2028.
The practical consequence is organisational. The AI Act work lands on a team that already holds a technical file and a relationship with a notified body, and the risk is not a missing procedure but a technical file that was never reopened, which is the same failure pattern as a management system certificate that is never exercised.
04What counts as a substantial modification?
A change you did not plan for and write down in advance.
| Change | New assessment | Why |
|---|---|---|
| Retraining within a documented plan | No | Predetermined and recorded |
| Swapping the base model | Yes | Affects compliance with Section 2 |
| Adding an output that feeds a decision | Yes | Changes the intended purpose |
| Raising a confidence threshold | Depends | Turns on effect on the requirements |
The exemption in Article 43(4) rewards foresight in a specific way. Changes in performance that the provider predetermined and documented in the technical documentation at the time of the initial assessment are not substantial modifications. A provider that describes its retraining regime in advance keeps its assessment valid through changes that would otherwise reopen it.
05Which route should a team plan for?
The one your Annex III point dictates, decided before the build rather than after it.
Write down the Annex III point, the resulting route, and the date the obligations apply: 2 December 2027 for Annex III systems, 2 August 2028 for Annex I products. If the point is 1, add one more line naming the harmonised standards you intend to apply, because that line is what decides whether a notified body is optional.
Then treat the internal route as the harder evidence problem rather than the easier one. Nobody external will tell you your file is thin before an authority does, and the artefacts that prevent that are the ordinary ones: a current technical documentation set, a logged risk management process, and a record of who reviewed what and when.
06Frequently asked questions
Does every high-risk AI system need a notified body?
No. Under Article 43(2), high-risk systems falling under points 2 to 8 of Annex III go through internal control under Annex VI, which involves no third party. A notified body is only in play for point 1, biometrics.
When is a notified body required for a biometric system?
Where the provider has not applied harmonised standards, or where those standards do not cover all the relevant requirements. If the standards exist and are applied in full, Article 43(1) lets the provider choose between Annex VI and Annex VII.
What about AI inside a regulated product?
Article 43(3) sends it to the conformity assessment procedure of the relevant Union harmonisation legislation listed in Annex I, with the AI Act requirements folded into that existing assessment rather than assessed separately.
Does retraining a model force a new conformity assessment?
Not if the change was planned. Article 43(4) excludes changes to performance that were predetermined by the provider and documented in the technical documentation at the time of the initial assessment. Unplanned changes that affect compliance or the intended purpose do trigger a new assessment.
07References and method
- Regulation (EU) 2024/1689, Article 43, for the two routes, the treatment of Annex I products in Article 43(3) and the substantial modification rule in Article 43(4).
- Article 43 of Regulation (EU) 2024/1689 in the consolidated presentation, checked on 17 September 2026 for the wording on harmonised standards and for the role of the market surveillance authority in law enforcement and migration uses.
- Regulation (EU) 2024/1689, Annex VI and Annex VII, for what each procedure requires, and Articles 47 and 48 for the declaration of conformity and the CE marking that follow it.
- Regulation (EU) 2026/1744, for the application dates of 2 December 2027 for Annex III and 2 August 2028 for Annex I, and for the amended Article 43(3) with its 28 January 2028 deadline for notified bodies under Annex I legislation to apply for designation.