S.L. 454.2 Art. 9Obligations of importers.

(1) Importers shall place only compliant instruments on the market.

(2) Before placing on the market an instrument intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2), importers shall ensure that the appropriate conformity assessment procedure referred to in regulation 14 has been carried out by the manufacturer. They shall ensure that the manufacturer has drawn up the technical documentation, that the instrument bears the CE marking and the supplementary metrology marking and is accompanied by the required documents, and that the manufacturer has complied with the requirements set out in regulation 7(5) and (6). Where an importer considers or has reason to believe that an instrument intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2) is not in conformity with the essential requirements set out in Schedule I, he shall not place the instrument on the market until it has been brought into conformity. Furthermore, where the instrument presents a risk, the importer shall inform the manufacturer and the Authority to that effect.

Before placing on the market an instrument not intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2) importers shall ensure that the manufacturer has complied with the requirements set out in regulation 7(5) and (6).

(3) Importers shall indicate on the instrument their name, registered trade name or registered trade mark and the postal address at which they can be contacted. Where this would require the packaging to be opened, those indications may be given on the packaging and in a document accompanying the instrument. The contact details shall be in at least English and, or Maltese.

(4) Importers shall ensure that the instrument intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2) is accompanied by instructions and information in a language which can be easily understood by end-users, as determined by the Authority.

(5) Importers shall ensure that, while an instrument intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2) is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements set out in Schedule I.

(6) When deemed appropriate with regard to the risks presented conforming instruments and instrument recalls, and shall keep distributors informed of any such monitoring.

(7) Importers who consider or have reason to believe that an instrument which they have placed on the market is not in conformity with these regulations shall immediately take the corrective measures necessary to bring that instrument into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the instrument presents a risk, importers shall immediately inform the Authority and the competent national authorities of the Member States in which they made the instrument available on the market to that effect, giving details, in particular, of the non-compliance and of any corrective measures taken.

(8) For the instruments intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2), importers shall, for 10 years after the instrument has been placed on the market keep a copy of the EU declaration of conformity at the disposal of the market surveillance authorities and ensure that the technical documentation can be made available to those authorities, upon request.

(9) Importers shall, further to a reasoned request from the Authority, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of an instrument in at least English and, or Maltese. They shall cooperate with that authority, at its request, on any action taken to eliminate the risks posed by instruments which they have placed on the market.