Art. 40c

inserted text (02016R0426-20260529)

Article 40c
Derogation from the conformity assessment procedures requiring the mandatory involvement of a notified body
1. By way of derogation from Article 14, a Member State may authorise, on a duly justified request from an economic operator, the placing on the market or use for the manufacturer’s own purposes within the territory of that Member State, of a specific appliance or fitting listed in the implementing act referred to in Article 40a(1) and for which the conformity assessment procedures referred to in Article 14 that require the mandatory involvement of a notified body have not been carried out but for which the compliance with all the applicable essential requirements laid down in Annex I 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 requirements laid down in Annex I, 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 appliance or fitting may be placed on the market or used for the manufacturer’s own purposes. 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 42(3).
The appliance or fitting subject to the extension of validity referred to in the first subparagraph shall bear the information that it is placed on the market or used for the manufacturer’s own purposes 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 42(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 appliances or fittings subject to the authorisation procedure referred to in paragraph 1 shall declare on their sole responsibility that the appliance or the fitting concerned complies with all the applicable essential requirements set out in Annex I 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 appliance or fitting may be placed on the market or used for the manufacturer’s own purposes. Such authorisations shall set out at least the following:
(a) a description of the procedures, by means of which compliance with the applicable essential requirements set out in Annex I to this Regulation was successfully demonstrated;
(b) any specific requirements regarding the traceability of the appliance or fitting 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 appliance or fitting concerned;
(e) measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the appliance or fitting concerned that has been placed on the market or used for the manufacturer’s own purposes.
7. By way of derogation from Articles 6, 16 and 17, appliances or fittings for which an authorisation has been granted in accordance with paragraph 1 of this Article shall not bear the CE marking and Article 6 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 appliances or fittings, 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
Regulation (EU) 2019/1020 of the European Parliament and of the Council of 20 June 2019 on market surveillance and compliance of products and amending Directive 2004/42/EC and Regulations (EC) No 765/2008 and (EU) No 305/2011 (OJ L 169, 25.6.2019, p. 1). 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 14.