S.L. 427.35 ст. 7Obligations.

(1) When placing their apparatus on the market, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential requirements set out in Schedule I.

(2) Manufacturers shall draw up the technical documentation referred to in Schedule II or Schedule III and carry out the relevant conformity assessment procedure referred to in regulation 14 or have it carried out.

(3) Where compliance of apparatus with the applicable requirements has been demonstrated by that procedure, manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

(4) Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the apparatus has been placed on the market.

(5) Manufacturers shall ensure that procedures are in place for series production to remain in conformity with these regulations. Changes in apparatus design or characteristics and changes in the harmonised standards or in other technical specifications by reference to which conformity of apparatus is declared shall be adequately taken into account.

(6) Manufacturers shall ensure that apparatus which they have placed on the market bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the apparatus does not allow it, that the required information is provided on the packaging or in a document accompanying the apparatus.

(7) Manufacturers shall indicate, on the apparatus, their name, registered trade name or registered trade mark and the postal address at which they can be contacted or, where that is not possible, on its packaging or in a document accompanying the apparatus. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be in a language easily understood by end-users and the MSD.

(8) Manufacturers shall ensure that the apparatus is accompanied by instructions and the information referred to in regulation 18, in Maltese or English. Such instructions and information, as well as any labelling, shall be clear, understandable and intelligible.

(9) Manufacturers who consider or have reason to believe that an apparatus which they have placed on the market is not in conformity with these regulations shall immediately take the corrective measures necessary to bring that apparatus into conformity, to withdraw it or recall it, if appropriate. Furthermore, where the apparatus presents a risk, manufacturers shall immediately inform the MSD, giving details, in particular, of the non-compliance and of any corrective measures taken.

(10) Manufacturers shall, further to a reasoned request from the MSD, provide it with all the information and documentation in paper or electronic form necessary to demonstrate the conformity of the apparatus with these regulations, in Maltese or English. They shall cooperate with the MSD, at its request, on any action taken to eliminate the risks posed by apparatus which they have placed on the market.