S.L. 427.30 Art. 17Market surveillance.

(1) Where the Technical Regulations Division takes any action pursuant to these regulations or Article 20 of Regulation

(EC) No 765/2008 or where it has sufficient reason to believe that transportable pressure equipment covered by these regulations presents a risk to the health or safety of persons or to other aspects of public interest protection covered by these regulations, it shall carry out an evaluation in relation to the transportable pressure equipment concerned covering all the requirements laid down in these regulations.

(2) The relevant economic operators shall cooperate as necessary with the Technical Regulations Division, including granting access to their premises and providing samples as appropriate.

(3) Where, in the course of that evaluation, the Technical Regulations Division finds that the transportable pressure equipment does not comply with the requirements set out in the Annexes to Directive 2008/68/EC and in these regulations, it shall without delay require the relevant economic operator to take all appropriate corrective action to bring the transportable pressure equipment into compliance with those requirements, to withdraw the transportable pressure equipment from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe. In such cases, Article 21 of Regulation

(EC) No 765/2008 shall apply to such corrective actions and the Technical Regulations Division shall inform the relevant notified body accordingly.

(4) Where the Technical Regulations Division considers that non-compliance is not restricted to the Maltese national territory, it shall inform the Commission and the other Member States of the results of the evaluation and of the actions which they have required the economic operator to take.

(5) The economic operator shall ensure that all appropriate corrective action is taken in respect of transportable pressure equipment that it has made available on the market.

(6) Where the relevant economic operator does not take adequate corrective action within the period referred to in the sub-regulation (3), the Technical Regulations Division shall take all appropriate provisional measures to prohibit or restrict the transportable pressure equipment being made available on the market, to withdraw the equipment from that market or to recall it.

The Technical Regulations Division shall inform the Commission and the other Member States, without delay, of those measures.

(7) The information referred to in sub-regulation (6) shall include all available details, in particular the data necessary for the identification of the non-compliant transportable pressure equipment, the origin of the equipment, the nature of the alleged noncompliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator. In particular, the Technical Regulations Division shall indicate whether the non-compliance is due to either:

(a) failure of the transportable pressure equipment to meet requirements relating to the health or safety of persons or to other aspects of public interest protection set out in the Annexes to Directive 2008/68/EC and in these regulations, or

(b) shortcomings in the standards or technical codes referred to in the Annexes to Directive 2008/68/EC or in other provisions of that Directive.

(8) Where procedures against the placing on the market of products are initiated in another Member State, the Technical Regulations Division shall without delay take the measures necessary to ensure that the non-compliant transportable pressure equipment is withdrawn from the local market and shall inform the Commission and the other Member States of any such measures adopted locally and of any additional information at its disposal relating to the non-compliance of the transportable pressure equipment concerned, or, in the event of disagreement with the notified measure, of its objections.

(9) Where, within two months of receipt of the information referred to in sub-regulation (6), no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by the Technical Regulations Division, that measure shall be deemed justified.

(10) The Technical Regulations Division shall ensure that appropriate restrictive measures are taken in respect of the transportable pressure equipment concerned, such as withdrawal of the transportable pressure equipment from their market, without delay.

(11) (a) Where, having performed an evaluation pursuant to sub-regulations (1) to (3), the Technical Regulations Division finds that although transportable pressure equipment is in compliance with Directive 2008/68/EC and these regulations, it presents a risk to the health or safety of persons or to other aspects of public interest protection, it shall require the relevant economic operator to take all appropriate measures to ensure that the transportable pressure equipment concerned, when placed on the market, no longer presents that risk, to withdraw the equipment from the market or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe.

(b) The economic operator shall ensure that corrective action is taken in respect of all the transportable pressure equipment concerned that he has made available on the market or is using throughout the Union.

(c) Where paragraph (a) applies, the Technical Regulations Division shall immediately inform the Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the transportable pressure equipment concerned, the origin and the supply chain of the equipment, the nature of the risk involved and the nature and duration of the national measures taken.

(12) (a) Without prejudice to the preceding regulations, where the Technical Regulations Division makes any of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(i) that the Pi marking has been affixed in violation of these regulations;

(ii) that the Pi marking has not been affixed;

(iii) that the technical documentation is either not available or not complete;

(iv) that the requirements of the Annexes to Directive 2008/68/EC and of these regulations have not been complied with.

(b) Where such non-compliance persists, the Technical Regulations Division concerned shall take all appropriate measures to restrict or prohibit the transportable pressure equipment being made available on the market or shall ensure that it is recalled or withdrawn from the market.