kimig

KI-MIG § 3

Competent authorities for the notification and accreditation of conformity assessment bodies

Official source ↗

(1) The authorities designated under federal or Land law as notifying authorities for the enforcement of the Union harmonisation legislation listed in Section A of Annex I to Regulation (EU) 2024/1689 also perform the tasks of the competent notifying authorities under Article 28(1) of Regulation (EU) 2024/1689 where AI systems are concerned that relate to products to which the rules listed in Section A of Annex I apply. For AI systems relating to products to which Regulation (EU) 2016/424 applies, the Länder designate the competent notifying authorities.

(2) For the high-risk AI systems under Article 6(2) in conjunction with point 1 of Annex III to Regulation (EU) 2024/1689, the market surveillance authority to be designated under Article 52(2) of Regulation (EU) 2024/2847 is the notifying authority competent under Article 28(1) of Regulation (EU) 2024/1689. Until the market surveillance authority is designated under Article 52(2) of Regulation (EU) 2024/2847, the Federal Office for Information Security (BSI) performs the task referred to in the first sentence.

(3) Where the notifying authority under subsection (1) or (2) has determined that a conformity assessment body meets the requirements of Article 31 of Regulation (EU) 2024/1689, it shall grant that body the authorisation to carry out conformity assessments within the meaning of Article 3, point (20), of Regulation (EU) 2024/1689 and shall notify it under Article 30(2) of Regulation (EU) 2024/1689 to the Commission and the other Member States. The authorisation may be granted subject to conditions or requirements (Bedingungen oder Auflagen). It may be granted for a limited period and subject to reservation of revocation and of subsequent requirements. It shall be granted subject to the suspensive condition that neither the European Commission nor the other Member States of the European Union raise objections to the notification.

(4) The assessment and monitoring of conformity assessment bodies within the meaning of Article 3, point (21), of Regulation (EU) 2024/1689 that are established in Germany is the responsibility of the bodies that already perform that task under the Union harmonisation legislation listed in Section A of Annex I to Regulation (EU) 2024/1689. By way of derogation from the first sentence, the assessment and monitoring of conformity assessment bodies within the meaning of Article 3, point (21), of Regulation (EU) 2024/1689 that are established in Germany and carry out conformity assessments for the high-risk AI systems referred to in point 1 of Annex III to Regulation (EU) 2024/1689 is the responsibility of the German national accreditation body (DAkkS).

(5) The authorities competent under subsections (1), (2) and (4) and DAkkS may call in experts from the scientific panel (Article 68 of Regulation (EU) 2024/1689) under Article 69 of Regulation (EU) 2024/1689.