Chapter 5a, Article 38c · Directive 2014/29/EU

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Article 38cDerogation from the conformity assessment procedures requiring the mandatory involvement of a notified body#

1.By way of derogation from Article 13, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market within the territory of that Member State, of specific vessels listed in the implementing act referred to in Article 38a(1) and for which the conformity assessment procedures referred to in Article 13 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential safety requirements of this Directive 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 safety requirements of this Directive, the Commission shall adopt, without delay, an implementing act extending 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 vessel may be placed on the market. 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 39(3).The vessel subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market 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 39(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 vessels subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the vessels concerned comply with all the applicable essential safety requirements of this Directive 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 vessel may be placed on the market. Such authorisations shall set out at least the following:

(a)a description of the procedures, by means of which the compliance with the applicable essential safety requirements of this Directive was successfully demonstrated;

(b)any specific requirements regarding the traceability of the vessel 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 vessel concerned;

(e)measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the vessel concerned that has been placed on the market.

7.By way of derogation from Articles 5, 15 and 16, vessels for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and the inscriptions provided for in point 1 of Annex III and Article 5 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 vessels, to take all corrective and restrictive actions at national level provided for under Regulation (EU) 2019/1020 of the European Parliament and of the Council^note and under this Directive. 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 13.

Defined terms · 18

Show every defined term

accreditation
means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
authorised representative
means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
conformity assessment
means the process demonstrating whether the essential safety requirements of this Directive relating to a vessel have been fulfilled;
conformity assessment body
means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
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 Council;
distributor
means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a vessel available on the market;
economic operators
means the manufacturer, the authorised representative, the importer and the distributor;
harmonised standard
means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;
importer
means any natural or legal person established within the Union who places a vessel from a third country on the Union market;
internal market emergency mode
means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.
making available on the market
means any supply of a vessel for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
manufacturer
means any natural or legal person who manufactures a vessel or has a vessel designed or manufactured, and markets that vessel under his name or trade mark;
national accreditation body
means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
placing on the market
means the first making available of a vessel on the Union market;
recall
means any measure aimed at achieving the return of a vessel that has already been made available to the end-user;
technical specification
means a document that prescribes technical requirements to be fulfilled by a vessel;
Union harmonisation legislation
means any Union legislation harmonising the conditions for the marketing of products;
withdrawal
means any measure aimed at preventing a vessel in the supply chain from being made available on the market;

Defined terms · 18

Show every defined term

accreditation
means accreditation as defined in point 10 of Article 2 of Regulation (EC) No 765/2008;
authorised representative
means any natural or legal person established within the Union who has received a written mandate from a manufacturer to act on his behalf in relation to specified tasks;
conformity assessment
means the process demonstrating whether the essential safety requirements of this Directive relating to a vessel have been fulfilled;
conformity assessment body
means a body that performs conformity assessment activities including calibration, testing, certification and inspection;
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 Council;
distributor
means any natural or legal person in the supply chain, other than the manufacturer or the importer, who makes a vessel available on the market;
economic operators
means the manufacturer, the authorised representative, the importer and the distributor;
harmonised standard
means harmonised standard as defined in point (c) of point 1 of Article 2 of Regulation (EU) No 1025/2012;
importer
means any natural or legal person established within the Union who places a vessel from a third country on the Union market;
internal market emergency mode
means internal market emergency mode as defined in Article 3, point (3), of Regulation (EU) 2024/2747.
making available on the market
means any supply of a vessel for distribution or use on the Union market in the course of a commercial activity, whether in return for payment or free of charge;
manufacturer
means any natural or legal person who manufactures a vessel or has a vessel designed or manufactured, and markets that vessel under his name or trade mark;
national accreditation body
means national accreditation body as defined in point 11 of Article 2 of Regulation (EC) No 765/2008;
placing on the market
means the first making available of a vessel on the Union market;
recall
means any measure aimed at achieving the return of a vessel that has already been made available to the end-user;
technical specification
means a document that prescribes technical requirements to be fulfilled by a vessel;
Union harmonisation legislation
means any Union legislation harmonising the conditions for the marketing of products;
withdrawal
means any measure aimed at preventing a vessel in the supply chain from being made available on the market;

Directive 2014/29/EU

Article 38cDerogation from the conformity assessment procedures requiring the mandatory involvement of a notified body#

Defined terms · 18

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Article 38cDerogation from the conformity assessment procedures requiring the mandatory involvement of a notified body#

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