S.L. 427.29 Art. 8Obligations of the manufacturer.

(1) When placing their pressure equipment or assemblies referred to in regulations 6(1) and 6(2) on the market or using them for their own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the essential safety requirements set out in Schedule 1.

(2) When placing their pressure equipment or assemblies referred to in regulation 6(3) on the market or using them for their own purposes, manufacturers shall ensure that they have been designed and manufactured in accordance with the sound engineering practice of a Member State.

(3) For the pressure equipment or assemblies referred to in regulation 6(1) and regulation 6(2), manufacturers shall draw up the technical documentation referred to in Schedule III and carry out the relevant conformity assessment procedure referred to in regulation 16 or have it carried out.

(4) Where compliance of the pressure equipment or assemblies referred to in regulation 6(1) and 6(2) with the requirements have been demonstrated by that procedure referred to in sub-regulation (3), manufacturers shall draw up an EU declaration of conformity and affix the CE marking.

(5) Manufacturers shall keep the technical documentation and the EU declaration of conformity for 10 years after the pressure equipment or assemblies has been placed on the market.

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

(7) When deemed appropriate with regard to the risks presented by pressure equipment or assemblies, manufacturers shall, to protect the health and safety of consumers and other users, carry out sample testing of pressure equipment or assemblies made available on the market, investigate, and, if necessary, keep a register of complaints, of non-conforming pressure equipment and recalls of such equipment and assemblies and recalls of such equipment, and shall keep distributors informed of any such monitoring.

(8) Manufacturers shall ensure that pressure equipment or assemblies bear a type, batch or serial number or other element allowing their identification, or, where the size or nature of the equipment or assembly does not allow it, that the required information is provided on the packaging or in a document accompanying the equipment.

(9) Manufacturers shall indicate on the pressure equipment or assembly 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 the packaging or in a document accompanying the equipment or assembly. The address shall indicate a single point at which the manufacturer can be contacted. The contact details shall be either in Maltese or English language.

(10) Manufacturers shall ensure that the pressure equipment or assemblies referred to in regulations 6(1) and 6(2) is accompanied by instructions and safety information in accordance with points 3.3 and 3.4 of Schedule I, in at least the Maltese or English language. Such instructions and safety information shall be clear, understandable and intelligible.

(11) Manufacturers shall ensure that the pressure equipment or assemblies referred to in regulation 6(3) are accompanied by instructions and safety information in accordance with regulation 6(3), in at least the Maltese or English language. Such instructions and safety information shall be clear, understandable and intelligible.

(12) Manufacturers who consider or have reason to believe that pressure equipment or assemblies which they have placed on the market is not in conformity with these regulations shall immediately take the corrective measures necessary to bring that pressure equipment or those assemblies into conformity, to withdraw it or recall it, if appropriate. Furthermore, where pressure equipment or assemblies presents a risk, manufacturers shall immediately inform the Technical Regulations Division to that effect, giving details, in particular, of the non-conformity and of any corrective measures taken.

(13) Manufacturers shall, further to a reasoned request from the Technical Regulations Division, provide it with all the information and documentation necessary to demonstrate the conformity of the pressure equipment or assembly with these regulations, in at least the Maltese or English language. That information and documentation may be provided in paper or electronic form. They shall cooperate with the Technical Regulations Division, at its request, on any action taken to eliminate the risks posed by the pressure equipment or assembly which they have placed on the market.