Chapter III — Conformity of products within the scope of this Regulation

Article 20 — Presumption of conformity of products within the scope of this Regulation¶

1. A product within the scope of this Regulation which is in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III covered by those standards or parts thereof.

2. The Commission shall, as provided in Article 10(1) of Regulation (EU) No 1025/2012, request one or more European standardisation organisations to draft harmonised standards for the essential health and safety requirements set out in Annex III.

3. The Commission may adopt implementing acts establishing common specifications covering technical requirements that provide a means to comply with the essential health and safety requirements set out in Annex III for products within the scope of this Regulation.

   (a) the Commission has requested, pursuant to Article 10(1) of Regulation (EU) No 1025/2012, one or more European standardisation organisations to draft a harmonised standard for the essential health and safety requirements set out in Annex III and:

   (i) the request has not been accepted; or

   (ii) the harmonised standards addressing that request are not delivered within the deadline set in accordance with Article 10(1) of Regulation (EU) No 1025/2012; or

   (iii) the harmonised standards do not comply with the request; and

   (b) no reference to harmonised standards covering the relevant essential health and safety requirements set out in Annex III 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.

   Those implementing acts shall only be adopted where the following conditions are fulfilled:

   Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).

4. Before preparing the draft implementing act referred to in paragraph 3, 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 3 have been fulfilled.

5. When preparing the draft implementing act referred to in paragraph 3, the Commission shall take into account the views of relevant bodies or the expert group and shall duly consult all relevant stakeholders.

6. A product within the scope of this Regulation which is in conformity with the common specifications established by implementing acts referred to in paragraph 3, or parts thereof, shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III covered by those common specifications or parts thereof.

7. Where a harmonised standard is adopted by a European standardisation organisation and proposed to the Commission for the purpose of publishing 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 the implementing acts referred to in paragraph 3, or parts thereof which cover the same essential health and safety requirements as those covered by that harmonised standard.

8. When a Member State considers that a common specification does not entirely satisfy the essential health and safety requirements set out in Annex III, it shall inform the Commission thereof by submitting a detailed explanation. The Commission shall assess that detailed explanation and may, if appropriate, amend the implementing act establishing the common specification in question.

9. Machinery and related products that have been certified or for which a statement of conformity has been issued under a cybersecurity certification scheme adopted in accordance with Regulation (EU) 2019/881 the references of which have been published in the Official Journal of the European Union shall be presumed to be in conformity with the essential health and safety requirements set out in Annex III, sections 1.1.9 and 1.2.1, as regards protection against corruption and safety and reliability of control systems insofar as those requirements are covered by the cybersecurity certificate or statement of conformity or parts thereof.

Article 21 — EU declaration of conformity of machinery and related products¶

1. The EU declaration of conformity shall state that the fulfilment of the applicable essential health and safety requirements set out in Annex III has been demonstrated.

2. The EU declaration of conformity shall have the model structure set out in Annex V, Part A, and shall contain the elements specified in the relevant modules set out in Annexes VI, VIII, IX, and X. It shall be continuously updated and shall be translated into the language or languages required by the Member State in which the machinery or related product is placed on the market, is made available on the market or put into service.

3. Where machinery or a related product is subject to more than one Union legal act that requires an EU declaration of conformity, a single EU declaration of conformity shall be drawn up in respect of all such acts. That declaration shall contain the identification of the Union legal acts concerned, including their publication references.

4. By drawing up the EU declaration of conformity, the manufacturer shall assume responsibility for the compliance of the machinery or related product with the requirements laid down in this Regulation.

Article 22 — EU declaration of incorporation of partly completed machinery¶

1. The EU declaration of incorporation shall state that the fulfilment of the relevant essential health and safety requirements set out in Annex III has been demonstrated.

2. The EU declaration of incorporation shall have the model structure set out in Annex V, Part B. It shall be continually updated and shall be translated into the language or languages required by the Member State in which the partly completed machinery is placed on the market or is made available on the market.

3. Where partly completed machinery is subject to more than one Union legal act requiring an EU declaration of conformity, the EU declaration of incorporation shall include a sentence declaring the conformity with such acts. That declaration shall contain the identification of the Union legal acts concerned, including their publication references.

4. By drawing up the EU declaration of incorporation, the manufacturer shall assume responsibility for the compliance of the partly completed machinery with the requirements laid down in this Regulation.

Article 23 — General principles of the CE marking¶

The CE marking shall be subject to the general principles set out in Article 30 of Regulation (EC) No 765/2008.

Article 24 — Rules for affixing the CE marking to machinery and related products¶

1. The CE marking shall be affixed visibly, legibly and indelibly to the machinery or related product. Where that is not possible or not warranted on account of the nature of the machinery or related product, it shall be affixed to the packaging and to the documents accompanying the machinery or related product.

2. The CE marking shall be affixed before the machinery or related product is placed on the market or put into service.

3. Where the conformity of machinery or a related product is assessed in accordance with the conformity assessment procedure referred to in Article 25(2), points (a), (b) and (c) and in Article 25(3), points (b), (c) and (d), the CE marking shall be followed by the identification number of the notified body involved in that procedure.

   The identification number of that notified body shall be affixed by the body itself or, under its instructions, by the manufacturer or the manufacturer’s authorised representative.

4. The CE marking and, where applicable, the identification number of the notified body may be followed by a pictogram or any other marking indicating a special risk or use.

5. Member States shall build upon existing mechanisms to ensure correct application of the regime governing the CE marking and shall take appropriate action in the event of improper use of that marking.