S.L. 427.61 Art. 29Market surveillance.

(1) The Technical Regulations Division shall take appropriate measures to ensure that products referred to in regulation 3(1) may be made available or put into service only if they do not endanger the health and safety of persons, property or the environment when correctly maintained and used in accordance with their intended purpose, and only on the condition that they meet the applicable essential requirements set out in Schedule I.

(2) Article 15(3) and Articles 16 to 29 of Regulation (EC) No 765/2008 shall apply to products covered by these regulations.

(3) Where the Technical Regulations Division has sufficient reasons to believe that a product covered by these regulations presents a risk to the health or safety of persons, to property or to the environment, they shall carry out an evaluation in relation to the product concerned covering all relevant requirements laid down in these regulations. The relevant economic operators or the private importer shall cooperate as necessary with the Technical the requirements laid down in these regulations, it shall without delay require the relevant economic operator to take the appropriate corrective action to bring the product into compliance with those requirements, to withdraw the product from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as it may prescribe. It shall also inform the Notified Body accordingly.

(b) In the case of a private importer, where, in the course of that evaluation, the Technical Regulations Division finds that the product does not comply with the requirements laid down in these regulations, the private importer shall be informed without delay of the appropriate corrective action to be taken to bring the product into compliance with those requirements, to suspend the putting into service of the product or to suspend the use of the product, commensurate with the nature of the risk. It shall also inform the Notified Body accordingly.

(5) Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in sub-regulation (4)(a) and (b).

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

(7) (a) The economic operator shall ensure that all appropriate corrective action is taken in respect of all the products concerned that it has made available on the market throughout the European Union.

(b) The private importer shall ensure that the appropriate corrective action is taken in respect of the product that he has imported in the European Union for his own use.

(8) (a) Where the relevant economic operator does not take adequate corrective action within the period referred to in sub-regulation (4)(a), the Technical Regulations Division shall take all appropriate provisional measures to prohibit or restrict the product being made available on the Maltese market, to withdraw the product from this market or to recall it.

(b) Where the private importer does not take adequate corrective action, the Technical Regulations Division shall take all appropriate provisional measures to prohibit the putting into service of the product, or prohibit or restrict the use of the product in the Maltese territory. include all available details, in particular the data necessary for the identification of the non-compliant product, the origin of the product, the nature of the non-compliance alleged and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the relevant economic operator or the private importer. In particular, the Technical Regulations Division shall indicate whether the non-compliance is due to either of the following:

(a) failure of the product to meet requirements relating to the health or safety of persons, the protection of property or the environment laid down in these regulations; or

(b) shortcomings in the harmonised standards referred to in regulation 15 conferring a presumption of conformity.

(11) When the procedure under this regulation is initiated by another Member State, the Technical Regulations Division shall without delay inform the European Commission and the other Member States of any measures adopted and of any additional information at their disposal relating to the non-compliance of the product concerned, and, in the event of disagreement with the adopted national measure, of their objections.

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

In such cases, the Technical Regulations Division shall ensure that appropriate restrictive measures are taken in respect of the product concerned, such as withdrawal of the product from the Maltese market, without delay.

(13) Where on completion of the procedure set out in sub-regulations (7) to (9), objections are raised against a measure taken by Technical Regulations Division, or where the European Commission considers a national measure to be contrary to European Union legislation, the European Commission shall without delay enter into consultation with the Member States and the relevant economic operator or operators or the private importer and shall evaluate the national measure. On the basis of the results of that evaluation, the Commission shall adopt an implementing act determining whether the national measure is justified or not. If, on the basis of this evaluation, the national measure is considered justified, the Technical Regulations Division shall ensure that the non-compliant product is withdrawn from the Maltese market and shall inform the European Commission accordingly. findings, it shall require the relevant economic operator or the private importer to put an end to the non-compliance concerned:

(a) the CE marking has been affixed in violation of regulation 17;

(b) the CE marking has not been affixed;

(c) the EU declaration of conformity or the declaration referred to in Schedule III has not been drawn up;

(d) the EU declaration of conformity or the declaration referred to in Schedule III has not been drawn up correctly;

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

(f) the information referred to in regulation 8(6) or regulation 10(3) is absent, false or incomplete;

(g) any other administrative requirement provided for in regulation 8 or regulation 10 is not fulfilled.

(15) Where the non-compliance referred to in sub-regulation

(14) persists, the Technical Regulations Division shall take all appropriate measures to restrict or prohibit the product being made available on the Maltese market or ensure that it is recalled or withdrawn from the Maltese market, or in the case of a product imported by a private importer for his own use, that its use is prohibited or restricted.