S.L. 427.41 Art. 39CDerogation from the conformity assessment procedures requiring the mandatory involvement of a notified body.

(1) By way of derogation from regulation 17, the TRD may authorise, on a duly justified request from an economic operator, the placing on the market in Malta of specific radio equipment referred to in regulation 39A(1) for which the conformity assessment procedures referred to in regulation 17 which require the mandatory involvement of a notified body have not been carried out:

Provided that compliance with all the relevant essential requirements established in regulation 4 has been determined in accordance with the procedures referred to in the said authorisation.

(2) The radio equipment subject to the authorisation referred to in sub-regulation (1) shall include the information that they are placed on the market as a crisis-relevant good.

(3) The information referred to in sub-regulation (2), as well as any labelling shall be clear, intelligible and which may be easily understood by consumers and other end-users, and where relevant, shall be written in the English or Maltese language.

(4) The authorisation granted by the TRD shall be valid only in Malta and on the territories of any other Member State whose competent authorities have recognised the validity of that authorisation before the adoption of the derogation referred to in sub-regulation (1).

(5) Manufacturers of radio equipment subject to the authorisation procedure referred to in sub-regulation (1) shall declare their sole responsibility that the radio equipment concerned complies with all the relevant essential requirements established in regulation 4 and shall be responsible for the fulfilment of all the conformity assessment procedures indicated by the TRD.

(6) Any authorisation issued pursuant to sub-regulation (1) shall establish the conditions and requirements under which the radio equipment may be placed on the market. Such authorisations shall establish at least the following:

(a) a description of the procedures, by means of which compliance with the relevant essential requirements established in regulation 4 was successfully demonstrated;

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

(c) an end date of validity of the authorisation, which may 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 radio equipment concerned;

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

(7) By way of derogation from regulations 9, 19 and 20, radio equipment for which an authorisation has been granted in accordance with sub-regulation (1) shall not contain the CE marking and regulation 9 shall not apply.

(8) Where an authorisation pursuant to sub-regulations (1), (2) and

(4) is valid, the MSD shall with regard to such radio equipment, take all corrective and restrictive actions provided for in accordance with the Market Surveillance and Compliance of Products Regulations.

(9) The use of the authorisation procedure provided in sub-regulations (1), (2) (4) and (6) shall not affect the application of the relevant conformity assessment procedures provided in regulation 17.