Article 46
Derogation from conformity assessment procedure

The text

What it requires, coded

SafeLegalAI's reading of each duty in this article: who, what, from when, under which fine tier, and whether it reaches a firm, chambers, court or legal-AI vendor. Descriptive, not advice; the quoted words are the Regulation's.

1. Art. 46(1)Derogation or exemptionHigh-risk

   A market surveillance authority may authorise specified high-risk AI systems before conformity assessment only for exceptional listed reasons, for a limited period, while assessment is completed without undue delay.

   "By way of derogation from Article 43 and upon a duly justified request, any market surveillance authority may authorise the placing on the market or the putting into service of specific high-risk AI systems within the territory of the Member State concerned, for exceptional reasons of public security or the protection of"

   Who

   Market surveillance authority

   From

   2026-08-02 (Art. 113 second subparagraph)

   Legal practice

   Institutional — Institutional governance mechanics; indirect relevance to legal practices through oversight and guidance.

   See

   Art. 43

2. Art. 46(2)Derogation or exemptionHigh-risk

   In urgent public-security or imminent physical-safety situations, law-enforcement or civil-protection authorities may use a system before authorisation if authorisation is promptly requested and use stops if refused.

   "In a duly justified situation of urgency for exceptional reasons of public security or in the case of specific, substantial and imminent threat to the life or physical safety of natural persons, law-enforcement authorities or civil protection authorities may put a specific high-risk AI system into service without the authorisation referred to"

   Who

   Market surveillance authority, Public-authority deployer

   From

   2026-08-02 (Art. 113 second subparagraph)

   Legal practice

   Institutional — Institutional governance mechanics; indirect relevance to legal practices through oversight and guidance.

3. Art. 46(3)Cooperation with authoritiesHigh-risk

   The derogation authorisation may be issued only if the system complies with Section 2, and the authority must inform the Commission and other Member States.

   "The authorisation referred to in paragraph 1 shall be issued only if the market surveillance authority concludes that the high-risk AI system complies with the requirements of Section 2. The market surveillance authority shall inform the Commission and the other Member States of any authorisation issued pursuant to paragraphs 1 and 2."

   Who

   Market surveillance authority

   From

   2026-08-02 (Art. 113 second subparagraph)

   Legal practice

   Institutional — Institutional governance mechanics; indirect relevance to legal practices through oversight and guidance.

   See

   Chapter III Section 2

4. Art. 46(5)Enforcement powerHigh-risk

   If objections are raised or the Commission considers an authorisation contrary to Union law or unfounded, it must consult the Member State and operators and decide whether authorisation is justified.

   "Where, within 15 calendar days of receipt of the notification referred to in paragraph 3, objections are raised by a Member State against an authorisation issued by a market surveillance authority of another Member State, or where the Commission considers the authorisation to be contrary to Union law, or the conclusion of"

   Who

   Commission

   From

   2026-08-02 (Art. 113 second subparagraph)

   Legal practice

   Institutional — Institutional governance mechanics; indirect relevance to legal practices through oversight and guidance.

5. Art. 46(6)Enforcement powerHigh-risk

   Where the Commission considers a derogation authorisation unjustified, the market surveillance authority of the Member State concerned must withdraw it.

   "Where the Commission considers the authorisation unjustified, it shall be withdrawn by the market surveillance authority of the Member State concerned."

   Who

   Market surveillance authority

   From

   2026-08-02 (Art. 113 second subparagraph)

   Legal practice

   Institutional — Institutional governance mechanics; indirect relevance to legal practices through oversight and guidance.

6. Art. 46(7)Derogation or exemptionHigh-risk

   For high-risk AI systems related to Annex I Section A products, only conformity-assessment derogations established in the relevant Union harmonisation legislation apply.

   "For high-risk AI systems related to products covered by Union harmonisation legislation listed in Section A of Annex I, only the derogations from the conformity assessment established in that Union harmonisation legislation shall apply."

   Who

   Market surveillance authority

   From

   2026-08-02 (Art. 113 second subparagraph)For high-risk AI systems that become high-risk through Art. 6(1) (Annex I products), corresponding obligations apply from 2027-08-02 under Art. 113(c).

   Legal practice

   Institutional — Institutional governance mechanics; indirect relevance to legal practices through oversight and guidance.

   See

   Annex I Section A · Art. 6(1)