Run a conformity assessment

• Annex III, point 1 (biometrics): where you applied harmonised standards or common specifications in full, you choose either route. Otherwise Article 43(1) requires Annex VII, with a notified body.
• Annex III, points 2 to 8: Annex VI internal control, with no notified body (Article 43(2)).
• Products under the legislation in Section A of Annex I: the conformity procedure that legislation sets (Article 43(3)).

The form suggests the route for the system you pick, and lets you choose either one.

1. Go to Compliance › AI Governance › Conformity assessments and click Start new assessment.
2. Under System, pick the AI system. Only high-risk systems still on the market are listed. Then choose the Reason: Initial — before market entry, Renewal, Substantial modification — Article 43(4) or Post-incident reassessment.
3. Under Procedure, choose the Route. The hint says which route Article 43 points the system to.
4. For Annex VII, enter the Notified body you engaged and, if you have it, its Identification number (its NANDO number). The register records the body you name; it doesn't check its designation.
5. Under Timing and ownership, set Started on, a Target completion date if you have one (nothing statutory runs from it), and an Internal owner from your workspace's members.
6. Under Annex IV technical pack, choose Reuse from system to use the pack already filed on the system, or Upload new pack to keep the version this assessment goes out with.
7. Click Start assessment.

The assessment gets a reference such as CA-0001 and shows In progress. The tab's count is the number of assessments in progress.

Open the assessment. Procedure history lists the route's steps and how many are complete.

1. Click Attach under a step and upload its evidence, a PDF or ZIP of up to 25 MB. Attaching a file alone leaves the step pending.
2. Click Mark done, then Record step. A step can't be marked done until its evidence is on file.
3. To undo a step, click Reopen and confirm with Reopen step. The evidence stays on file.

Evidence is listed in Documents as Article 43 procedure step, and each step recorded appears under the assessment's Activity.

1. Click Record conclusion.
2. Enter the date it was Concluded on and choose the Outcome: Conformity confirmed or Conformity refused. A refusal needs Findings saying what has to change.
3. On the Annex VII route, when conformity is confirmed, enter the Certificate number and the Valid until date from the notified body's certificate.
4. Click Record conclusion.

The table's Issued column shows the conclusion date. Internal control under Annex VI ends in your own declaration, so there's no certificate to record. Under Article 44(2), a notified body's certificate is valid for at most five years for an Annex I system and four years for an Annex III system, and can be extended for further periods on re-assessment.

The register treats a certificate as expiring soon from 60 days before its Valid until date. The table's Valid until column shows how long each certificate has left, and the Next renewal tile shows the earliest expiry and how many certificates are within those 60 days.

To renew, open the menu on the certificate's row and choose Renew. It's offered on Annex VII assessments that confirmed conformity with a certificate. The assessment form opens with the system, the Annex VII route and the Renewal reason filled in, and nothing is saved until you click Start assessment.

Each system's drawer shows its standing under Conformity: Not started, Assessment in progress, Conformity confirmed, Certificate expired or Conformity refused. An expired certificate shows as expired even while a renewal is in progress.