Machinery Regulation

02023R1230-20230629 → 02023R1230-20260529

Article 3 Definitions For the purposes of this Regulation, the following definitions apply: (1) machinery means: (a) an assembly, fitted with or intended to be fitted with a drive system other than directly applied human or animal effort, consisting of linked parts or components, … 1,378 unchanged words … Regulation, written in a programming language so that it is unambiguous and understandable to humans; (36) professional user means a natural person who uses or operates machinery or a related product in the course of his or her professional activity or work. work; (37) crisis-relevant goods means crisis-relevant goods as defined in Article 3, point (6), of Regulation (EU) 2024/2747 of the European Parliament and of the CouncilRegulation (EU) 2024/2747 of the European Parliament and of the Council of 9 October 2024 establishing a framework of measures, related to an internal market emergency and to the resilience of the internal market and amending Council Regulation (EC) No 2679/98 (Internal Market Emergency and Resilience Act) (OJ L, 2024/2747, 8.11.2024, ELI: http://data.europa.eu/eli/reg/2024/2747/oj).; (38) internal market emergency mode means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.

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Article 25a
Application of emergency procedures
1. Articles 25b to 25e of this Regulation shall apply only if the Commission has adopted an implementing act pursuant to Article 28 of Regulation (EU) 2024/2747 with respect to machinery and related products covered by this Regulation.
2. Articles 25b to 25e of this Regulation shall apply only to machinery and related products which have been designated as crisis-relevant goods pursuant to Article 18(4) of Regulation (EU) 2024/2747.
3. Articles 25b to 25e of this Regulation shall apply only during the internal market emergency mode that has been activated in accordance with Article 18 of Regulation (EU) 2024/2747.
However, Article 25c(7) of this Regulation shall apply during the internal market emergency mode and after its expiry or deactivation.
4. The Commission may adopt implementing acts regarding the corrective or restrictive actions to be taken, the procedures to be followed and the specific labelling and traceability requirements with respect to machinery and related products placed on the market or put into service in accordance with Articles 25c and 25d. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 48(3).

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Article 25b
Prioritisation of the conformity assessment of machinery and related products designated as crisis-relevant goods
1. This Article applies to all types of machinery and related products listed in the implementing act referred to in Article 25a(1) that are subject to the conformity assessment procedures referred to in Article 25 that require the mandatory involvement of a notified body.
2. The notified bodies shall make best efforts to process as a matter of priority all applications for a conformity assessment of machinery and related products referred to in paragraph 1 of this Article, irrespective of whether those applications have been lodged before or after the activation of the emergency procedures pursuant to Article 25a.
3. The prioritisation of applications for a conformity assessment of machinery and related products pursuant to paragraph 2 shall not result in additional disproportionate additional costs for the manufacturers, who have lodged those applications.
4. The notified bodies shall make reasonable efforts to increase their testing capacities for machinery and related products referred to in paragraph 1 in respect of which they have been notified.

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Article 25c
Derogation from conformity assessment procedures requiring the mandatory involvement of a notified body
1. By way of derogation from Article 25, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market or putting into service within the territory of that Member State, of specific machinery or related products listed in the implementing act referred to in Article 25a(1) and for which the conformity assessment procedures referred to in Article 25 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential health and safety requirements set out in Annex III has been demonstrated in accordance with procedures referred to in that authorisation.
2. The Member State shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with paragraph 1 of this Article. Provided that the requirements set out in the authorisation ensure conformity with the applicable essential health and safety requirements laid down in Annex III, the Commission shall adopt, without delay, an implementing act extending for a limited period of time the validity of the authorisation granted by a Member State in accordance with paragraph 1 of this Article to the territory of the whole Union and shall set out the conditions under which the specific machinery or related products may be placed on the market or put into service. When preparing the draft implementing act, the Commission may request national market surveillance authorities to provide relevant information or comments regarding the technical assessment that served as the basis for the authorisation referred to in paragraph 1 of this Article. The implementing act shall be adopted in accordance with the examination procedure referred to in Article 48(3).
The machinery or related products subject to the extension of validity referred to in the first subparagraph shall bear the information that they are placed on the market or put into service as a crisis-relevant good. The implementing act referred to in the first subparagraph shall specify the content and presentation of that information. That information, as well as any labelling, shall be clear, understandable and intelligible and, where relevant, in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
3. On duly justified imperative grounds of urgency relating to the need to preserve the health and safety of persons, the Commission shall adopt immediately applicable implementing acts in accordance with the procedure referred to in Article 48(4).
4. As long as an implementing act as referred to in paragraph 2 or 3 is not adopted, the authorisation granted by a competent national authority in one Member State shall be valid only on the territory of that Member State, and on the territories of any other Member States whose competent national authorities have recognised the validity of that authorisation before the adoption of such an implementing act. Member States shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.
5. Manufacturers of machinery or of related products subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the machinery or the related products concerned comply with all the applicable essential health and safety requirements set out in Annex III and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the competent national authority.
6. Any authorisation issued pursuant to paragraph 1 shall set out the conditions and requirements under which the machinery or the related products may be placed on the market or put into service. Such authorisations shall set out at least the following:
(a) a description of the procedures by means of which compliance with the applicable essential health and safety requirements set out in Annex III to this Regulation was successfully demonstrated;
(b) any specific requirements regarding the traceability of the machinery and the related products concerned;
(c) an end date of validity of the authorisation, which cannot go beyond the last day of the period for which the internal market emergency mode has been activated in accordance with Article 18 of Regulation (EU) 2024/2747;
(d) any specific requirements regarding the need to ensure a continuous conformity assessment with respect to the machinery and the related products concerned;
(e) measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the machinery or the related products concerned that have been placed on the market or put into service.
7. By way of derogation from Articles 4, 23 and 24, machinery or related products for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 4 shall not apply.
8. The market surveillance authorities of a Member State where an authorisation pursuant to paragraphs 1, 2 and 4 of this Article is valid shall be entitled, with respect to such machinery and related products, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 and under this Regulation. They shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.
9. The use of the authorisation procedure set out in paragraphs 1 to 4 of this Article shall not affect the application on the territory of the Member State concerned of the relevant conformity assessment procedures laid down in Article 25.

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Article 25d
Presumption of conformity based on standards and common specifications
1. Where machinery or related products have been designated as crisis-relevant goods, the Commission is empowered to adopt implementing acts, listing appropriate standards or establishing common specifications for such machinery or related products to cover the applicable essential health and safety requirements set out in Annex III to this Regulation in the following cases:
(a) where a reference to harmonised standards covering the applicable essential health and safety requirements set out in Annex III to this Regulation has not 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; or
(b) where severe disruptions to the functioning of the internal market, which led to the activation of the internal market emergency mode in accordance with Article 18 of Regulation (EU) 2024/2747, significantly restrict the possibilities of manufacturers to make use of the harmonised standards that cover the applicable essential health and safety requirements set out in Annex III to this Regulation and the references of which have already been published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012.
2. The implementing acts referred to in paragraph 1 shall set out the most appropriate alternative technical solution for the purposes of providing a presumption of conformity in accordance with paragraph 5. To that end, references of European standards or references of relevant applicable national or international standards may be published in those implementing acts or, if there is no European standard or relevant applicable national or international standard, common specifications may be established by those implementing acts.
3. The implementing acts referred to in paragraph 1 of this Article shall be adopted in accordance with the examination procedure referred to in Article 48(3) and shall apply until the last day of the period during which the internal market emergency mode is activated, unless such implementing acts are amended or repealed in accordance with paragraph 7 of this Article.
4. Before preparing the draft implementing act referred to in paragraph 1 of this Article, 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 of this Article have been fulfilled. When preparing that draft implementing act, the Commission shall take into account the views of relevant bodies or expert groups established under this Regulation and shall duly consult all relevant stakeholders.
5. Without prejudice to Article 20, machinery and related products that are in conformity with the standards or common specifications referred to in paragraph 1 of this Article, or parts thereof, shall be presumed to be in conformity with the applicable essential health and safety requirements set out in Annex III that are covered by those standards, common specifications or parts thereof. From the day following the expiry or deactivation of the internal market emergency mode, it shall no longer be possible for manufacturers to rely on the presumption of conformity provided by the standards or the common specifications referred to in the implementing acts referred to in paragraph 1 of this Article.
6. By way of derogation from Article 25a(3), first subparagraph, unless there is sufficient reason to believe that the machinery and the related products covered by the standards or common specifications referred to in paragraph 1 of this Article present a risk to the health or safety of persons, the machinery and the related products that are in conformity with those standards or common specifications and which have been placed on the market or put into service shall be deemed to be in conformity with the applicable essential health and safety requirements set out in Annex III after the expiry or repeal of an implementing act adopted pursuant to paragraph 3 of this Article and after the expiry or deactivation of the internal market emergency mode.
7. When a Member State considers that a standard or common specification referred to in paragraph 1 does not entirely satisfy the applicable 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 or repeal the implementing act listing the standard or establishing the common specification in question.

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Article 25e
Prioritisation of market surveillance activities and mutual assistance among authorities
1. The Member States shall prioritise the market surveillance activities for machinery and related products listed in the implementing act referred to in Article 25a(1) of this Regulation. The Commission shall facilitate coordination of such prioritisation efforts through the Union Product Compliance Network established under Article 29 of Regulation (EU) 2019/1020.
2. The market surveillance authorities of the Member States shall ensure that best efforts are made to provide assistance to other market surveillance authorities during an internal market emergency mode, including by mobilising and dispatching expert teams to temporarily reinforce the staff of market surveillance authorities requesting assistance or by providing logistical support, such as the reinforcement of the testing capacity for machinery and the related products listed in the implementing act referred to in Article 25a(1).

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