S.L. 427.39 Art. 22Market surveillance.

(1) Regulation 15(3) and regulations 16 to 29 of regulation (EC) No 765/2008 shall apply to products covered by Schedule 1 of these regulations.

(2) Where the market surveillance authorities have sufficient reason to believe that a product presents a risk to the health or safety of persons or to domestic animals or property, 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 shall cooperate as necessary with the market surveillance authorities for that purpose.

(3) Where, in the course of the evaluation referred to sub-regulation (1), the market surveillance authorities find that the product does not comply with the requirements laid down in these regulations, they shall without delay require the relevant economic operator to take all appropriate corrective actions 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 they may prescribe.The market surveillance authorities shall inform the relevant notified body accordingly.

(4) Regulation 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in the sub-regulation (3).

(5) Where the market surveillance authorities consider that non-compliance is not restricted to their national territory, they 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.

(6) 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 Union.

(7) Where the relevant economic operator does not take adequate corrective action within the period referred to in sub-regulation (3), the Technical Regulations Division shall take all appropriate provisional measures to prohibit or restrict the products being made available on their national market, to withdraw the product from that market or to recall it. The market surveillance authorities shall inform the European Commission and the other Member States, without delay, of those measures.

(8) The information referred to in the regulation 8 shall 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. 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 or to the protection of domestic animals or property; or

(b) shortcomings in the harmonised standards referred to in regulation 14 conferring a presumption of conformity.

(9) 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 product concerned, and, in the event of disagreement with the adopted national measure, of their objections.

(10) Where, within three months of receipt of the information referred to in sub-regulation (7), 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.

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

(12) Where on completion of the procedure set out in sub-regulations (6) and (7), objections are raised against the measures taken by Technical Regulations Division; the European Commission shall conduct an evaluation including appropriate consultations with these entities and the relevant economic operator or operators.

(13) If, on the basis of this evaluation, the national measure is considered justified, the Technical Regulations Division shall take the necessary measures to ensure that the placing on the market or use non-compliant product is withdrawn from the Maltese market, and shall inform the European Commission accordingly. If, on the basis of this evaluation, the national measure is considered unjustified, the national measure shall be withdraw.

(14) Where, having carried out an evaluation under sub-regulation (2), the Technical Regulations Division finds that although a product is in compliance with these Regulations, it presents a risk to the health or safety of persons or to domestic animals or property, it shall require the relevant economic operator to take all appropriate measures to ensure that the product concerned, when placed on the market, no longer presents that risk, 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.

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

(16) The Technical Regulations Division, upon consultation with the Commissioner of Police, shall immediately inform the European Commission and the other Member States. That information shall include all available details, in particular the data necessary for the identification of the product concerned, the origin and the supply chain of the product, the nature of the risk involved and the nature and duration of the national measures taken.

(17) Without prejudice to sub-regulations (2) to (11), where the Technical Regulations Division and/or the Commissioner of Police makes one of the following findings, it shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) the CE marking has been affixed in violation of article 30 of Regulation (EC) No 765/2008 or of regulation 17 of these regulations;

(b) the CE marking, where required, has not been affixed;

(c) the specific marking of explosion protection , the symbols of the equipment-group and category and, where applicable, the other markings and information have been affixed in violation of point 1.0.5 of Schedule II or have not been affixed;

(d) the identification number of the notified body, where that body is involved in the production control phase, has been affixed in violation of regulation 17 or has not been affixed;

(e) the EU declaration of conformity or the attestation of conformity, as appropriate, does not accompany the product;

(f) the EU declaration of conformity or, where required, the attestation of conformity has not been drawn up correctly;

(g) technical documentation is either not available or not complete;

(h) the information referred to in regulation 8(7) or 10(3) is absent, false or incomplete;

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

(19) Where the non-compliance referred to in sub-regulation (1) persists, the Technical Regulations Division concerned shall take all appropriate measures to restrict or prohibit the product being made available on the market or ensure that it is recalled or withdrawn from the Maltese market.