S.L. 427.36 Art. 18CDerogation from the conformity assessment procedures requiring the mandatory involvement of a notified body.

(1) By way of derogation from regulation 11 the TRD may authorise, on a duly justified request from an economic operator, the placing on the market or putting into service in Malta of specific machinery referred to in regulation 18A(1) for which the conformity assessment procedures referred to in regulation 11 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 provided in these regulations shall be demonstrated in accordance with procedures referred to in the respective authorisation. The TRD shall immediately inform the Commission and the other Member States of any authorisation granted in accordance with this sub-regulation.

(2) The machinery, subject to the extension of validity of the authorisation pursuant to sub-regulation (1), shall bear the information that it is placed on the market or put into service as a crisis-relevant good. The information and any labelling shall be clear, intelligible and be written in the English or Maltese language.

(3) The authorisation granted by the TRD 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 TRD shall inform the Commission and the other Member States of any decision to recognise the validity of that authorisation.

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

(5) Any authorisation issued pursuant to sub-regulation (1) shall establish the conditions and requirements under which the machinery may be placed on the market or put into service in Malta. The authorisations shall provide 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 I was successfully demonstrated;

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

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

(6) By way of derogation from regulations 7 and 14, machinery for which an authorisation has been granted in accordance with sub-regulation (1) shall not bear the CE marking and regulation 7 shall not apply.

(7) Where an authorisation pursuant to sub-regulations (1) and

(3) is valid the TRD shall with respect to the machinery take all corrective and restrictive actions provided for in accordance with the

Market Surveillance and Compliance of Products Regulations and these regulations. The TRD 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 established in regulation 11.