S.L. 454.2 Art. 7Obligations of manufacturers.

(1) When placing on the market their instruments intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2), manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Schedule I.

(2) For the instruments intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2), manufacturers shall draw up the technical documentation referred to in Schedule II and carry out the relevant conformity assessment procedure referred to in regulation 14 or have it carried out . Where compliance of an instrument intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2) with the applicable requirements has been demonstrated by that conformity assessment procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking and the supplementary metrology marking.

(3) For the instruments intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2), manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the instrument has been placed on the market.

(4) Manufacturers shall ensure that procedures are in place for series production to remain in conformity with these regulations. Changes in instrument design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of an instrument is declared shall be adequately taken into account. When deemed appropriate with regard to the risks presented by an instrument intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2), manufacturers shall carry out sample testing of instruments made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming instruments and instrument recalls, and shall keep distributors informed of any such monitoring.

(5) Manufacturers shall ensure that instruments which they have placed on the market bear a type, batch or serial number or other element allowing their identification, as set out in Schedule III.

For the instruments intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2), manufacturers shall affix the inscriptions provided for in point 1 of Schedule III. For the instruments not intended to be used for the applications listed in paragraphs (a) to (f) of regulation 2(2), manufacturers shall affix the inscriptions provided for in point 2 of Schedule III. regulation 2(2), manufacturers shall affix to each of those devices the restrictive use symbol as provided for in regulation 19 and in point 3 of Schedule III.

(6) Manufacturers shall indicate on the instrument their name, registered trade name or registered trade mark and the postal address at which they can be contacted. The address shall indicate a single paragraph at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and the Authority.

(7) Manufacturers 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. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible.

(8) Manufacturers 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, manufacturers 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.

(9) Manufacturers 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 the instrument with these regulations, in at least English and, or Maltese. They shall cooperate with the Authority, at its request, on any action taken to eliminate the risks posed by instruments which they have placed on the market.