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Article 41

Common Specifications

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

1. The Commission is empowered to adopt, after consulting the Advisory Forum referred to in Article 58a, implementing acts in accordance with the examination procedure referred to in Article 74(2) establishing common specifications for the requirements set out in Chapter 2 of this Title or, as applicable, with requirements set out in Article [GPAI Chapter], for AI systems within the scope of this Regulation, where the following conditions have been fulfilled:

  1. the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Chapter 2 of this Title; and
    (i) the request has not been accepted by any of the European standardisation organisations; or
    (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with article 10(1) of Regulation 1025/2012; or
    (iii) the relevant harmonised standards insufficiently address fundamental rights concerns; or
    (iv) the harmonised standards do not comply with the request; and
  2. no reference to harmonised standards covering the requirements referred to in Chapter II of this Title has been published in the Official Journal of the European Union, in accordance with Regulation (EU) No 1025/2012, and no such reference is expected to be published within a reasonable period.

1a. Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation EU (No) 1025/2012 that it considers that the conditions in paragraph 1 are fulfilled.

3. High-risk AI systems which are in conformity with the common specifications referred to in paragraph 1, or parts thereof, shall be presumed to be in conformity with the requirements set out in Chapter 2 of this Title, to the extent those common specifications cover those requirements.

3a. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the publication of its reference in the Official Journal of the European Union, the Commission shall assess the harmonised standard in accordance with Regulation (EU) No 1025/2012. When reference of a harmonised standard is published in the Official Journal of the European Union, the Commission shall repeal acts referred to in paragraph 1 and 1b, or parts thereof which cover the same requirements set out in Chapter 2 of this Title.

4. Where providers of high-risk AI systems do not comply with the common specifications referred to in paragraph 1, they shall duly justify that they have adopted technical solutions that meet the requirements referred to in Chapter II to a level at least equivalent thereto.

4b. When a Member State considers that a common specification does not entirely satisfy the requirements set out in Chapter 2 of this Title, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification in question.

[Previous version]

1. The Commission is empowered to adopt, after consulting the AI Board referred to in Article 56, implementing acts in accordance with the examination procedure referred to in Article 74(2) establishing common technical specifications for the requirements set out in Chapter 2 of this Title, or, as applicable, with requirements set out in Article 4a and Article 4b, where the following conditions have been fulfilled:

  1. no reference to harmonised standards covering the relevant essential safety or fundamental right concerns is published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012;
  1. the Commission has requested, pursuant to Article 10(1) of Regulation 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the requirements set out in Chapter 2 of this Title;
  1. the request referred to in point (b) has not been accepted by any of the European standardisation organisations or the harmonised standards addressing that request are not delivered within the deadline set in accordance with article 10(1) of Regulation 1025/2012 or those standards do not comply with the request.

1a. Before preparing a draft implementing act, the Commission shall inform the committee referred to in Article 22 of Regulation EU (No) 1025/2012 that it considers that the conditions in paragraph 1 are fulfilled.

2. In the early preparation of the draft implementing act establishing the common specification, the Commission shall fulfil the objectives referred to in Article 40(2) and gather the views of relevant bodies or expert groups established under relevant sectorial Union law. Based on that consultation, the Commission shall prepare the draft implementing act.

3. High-risk AI systems or general purpose AI systems which are in conformity with the common specifications referred to in paragraph 1 shall be presumed to be in conformity with the requirements set out in Chapter 2 of this Title or, as applicable, with requirements set out in Article 4a and Article 4b, to the extent those common specifications cover those requirements.

4. When references of a harmonised standard are published in the Official Journal of the European Union, implementing acts referred to in paragraph 1, which cover the requirements set out in Chapter 2 of this Title or requirements set out in Article 4a and Article 4b, shall be repealed, as applicable.

5. When a Member State considers that a common specification does not entirely satisfy the requirements set out in Chapter 2 of this Title or requirements set out in Article 4a and Article 4b, as applicable, it shall inform the Commission thereof with a detailed explanation and the Commission shall assess that information and, if appropriate, amend the implementing act establishing the common specification in question.

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