S.L. 427.29 Art. 29CDerogation from the conformity assessment procedures requiring the mandatory involvement of a notified body.

(1) By way of derogation from regulation 16, 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 specific pressure equipment or assembly referred to in regulation

29A(1) for which the conformity assessment procedures referred to in regulation 16 which require the mandatory involvement of a notified body have not been carried out:

Provided that compliance with all the applicable essential safety requirements established in Schedule I 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 pressure equipment or assemblies subject to the extension of validity referred to in sub-regulation (1) shall bear the information that they are placed on the market or used for the manufacturer’s own purposes as a "crisis-relevant good". The information and any labelling shall be clear and intelligible and shall be written in the English or Maltese language.

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

(4) Manufacturers of pressure equipment or assemblies subject to the extension of validity of the authorisation procedure referred to in sub-regulation (1) shall declare on their sole responsibility that the pressure equipment or assembly concerned complies with all the applicable essential safety requirements established in Schedule I 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 pressure equipment or assembly 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 safety requirements established in Schedule I was successfully demonstrated;

(b) any specific requirements regarding the traceability of the pressure equipment or assembly 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 pressure equipment or assembly concerned;

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

(6) By way of derogation from regulations 7, 20 and 21, pressure equipment or assemblies 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 Technical Regulations Division shall, with respect to such pressure equipment or assemblies, take all corrective and restrictive actions provided for under the Market Surveillance and Compliance of Products 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 (3) shall not affect the application of the relevant conformity assessment procedures established in regulation 16.