S.L. 427.39 ст. 22CDerogation from the conformity assessment procedures requiring the mandatory involvement of a notified body.

(1) By way of derogation from regulation 15, the Technical

Regulations Division may authorise, following a duly justified request from an economic operator, the placing on the market or use for the manufacturer’s own purposes in Malta, of a specific product for which the conformity assessment procedures referred to in regulation 15

which require the mandatory involvement of a notified body have not been carried out:

Provided that compliance with all the applicable essential health and safety requirements established in Schedule II has been demonstrated in accordance with procedures referred to in such authorisation. The Technical Regulations Division shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with this sub-regulation.

(2) The product subject to the extension of validity of the authorisation referred to in sub-regulation (1) shall bear the information that it is placed on the market or used for the manufacturer’s own purposes as a crisis-relevant good. Such information, as well as any labelling shall be clear, intelligible, and where relevant, shall be written in the English or Maltese language.

(3) The authorisation granted by Technical Regulations Division in accordance with sub-regulation (1) shall be valid only in Malta unless it has been recognised as valid by a national market surveillance authority in another Member State. The Technical Regulations Division shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

(4) Manufacturers of products subject to the authorisation procedure referred to in sub-regulation (1) shall declare on their sole responsibility that the product concerned complies with all the applicable essential health and safety requirements established in Schedule II and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the Technical Regulations Division.

(5) Any authorisation issued in accordance with sub-regulation (1) shall establish the conditions and requirements under which the product may be placed on the market or used for the manufacturer’s own purposes. Such authorisations shall establish at least the following:

(a) a description of the procedures by means of which compliance with the applicable essential health and safety requirements established in Schedule II was successfully demonstrated;

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

(c) an end date of validity of the authorisation, which shall not 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 product concerned;

(e) measures to be taken upon expiry or deactivation of the internal market emergency mode with respect to the products concerned that have been placed on the market or used for the manufacturer’s own purposes.

(6) By way of derogation from regulations 9 and 17, products for which an authorisation has been granted in accordance with sub-regulation (1) shall not bear the CE marking and regulation 9 shall not apply.

(7) Where an authorisation pursuant to sub-regulations (1) and (3) is valid, the Technical Regulations Division shall with respect to such products take all corrective and restrictive actions provided for under the Market Surveillance and Compliance of Products Regulations and these regulations. The Technical Regulations Division shall immediately inform the Commission and the market surveillance authorities of all other Member States of these actions.

(8) The use of the authorisation procedure established in sub-regulations (1) and (2) shall not affect the application of the relevant conformity assessment procedures stipulated in regulation 15.