S.L. 427.60 Art. 17Market surveillance.

(1) As regards marine equipment, the Technical

Regulations Division and the Registrar-General shall undertake market surveillance in accordance with the EU market surveillance framework laid down in Chapter III of Regulation (EC) No 765/ 2008, subject to sub-regulations (2) and (3).

(2) Market surveillance infrastructures and programmes shall take into account the specific features of the marine equipment sector, including the various procedures carried out as part of the conformity assessment, and in particular the responsibilities placed on the flag State administration by the international conventions.

(3) Market surveillance may include documentary checks as well as checks of marine equipment which bears the wheel mark, whether or not it has been placed on board ships. Checks of marine equipment already placed on board shall be limited to such examination as can be carried out while the equipment concerned remains fully functional on board.

(4) Where the Technical Regulations Division and the Registrar-General intend to carry out sample checks, they may, when it is reasonable and practicable to do so, request the manufacturer to make the necessary samples available or to give on-the-spot access to the samples at the manufacturer’s own cost.

(5) Where the Technical Regulations Division and, or the Registrar-General has sufficient reasons to believe that marine equipment covered by these regulations presents a risk to maritime safety, to health or to the environment, they shall carry out an

(6) Where, in the course of that evaluation, the Technical Regulations Division and, or the Registrar-General find that the marine equipment 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 marine equipment into compliance with those requirements, to withdraw the marine equipment from the market, or to recall it within such reasonable period, commensurate with the nature of the risk, as they may prescribe.

(7) The Technical Regulations Division and, or the Registrar-General shall inform the relevant notified body accordingly.

(8) Article 21 of Regulation (EC) No 765/2008 shall apply to the measure referred to in sub-regulation (6).

(9) Where the Technical Regulations Division and, or the Registrar-General considers that non-compliance is not restricted to the Maltese territory or to ships flying the Maltese flag, they shall inform the European Commission and the other Member States, by means of the information system made available by the European Commission for market surveillance purposes, of the results of the evaluation carried out under sub-regulations (5) to (8) and of the actions which they have required the economic operator to take.

(10) 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 or, as the case may be, placed or delivered to be placed on board EU ships.

(11) Where the relevant economic operator does not take adequate corrective action within the period prescribed by the Technical Regulations Division and, or the Registrar-General in accordance with sub-regulation (6), or otherwise fails to meet its obligations under these regulations, the Technical Regulations Division and, or the Registrar-General shall take all appropriate provisional measures to prohibit or restrict the marine equipment being made available on the Maltese market or placed on board ships flying the Maltese flag, to withdraw the product from the market or to recall it.

(12) The Technical Regulations Division and, or the Registrar-General shall inform the European Commission and the other Member States, without delay, of those measures.

(13) The information on the measures taken by the Technical Regulations Division and, or the Registrar-General referred to in sub-regulation (11) shall include all available details, in particular the data necessary for the identification of the non-compliant marine equipment, the origin of the product, the nature of the alleged non-compliance and the risk involved, the nature and duration of the national measures taken and the arguments put forward by the economic operator concerned. In particular, the requirements as laid down pursuant to regulation 5;

(b) non-compliance with the testing standards referred to in regulation 5 during the conformity assessment procedure;

(c) shortcomings in those testing standards.

(14) When the procedure under this regulation is initiated by another Member State, the Technical Regulations Division and, or the Registrar-General 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 marine equipment concerned, and, in the event of disagreement with the notified national measure, of their objections.

(15) Where, within four months of receipt of the information concerning the measures taken by the market surveillance authorities, as referred to in sub-regulation (11), no objection has been raised by a Member State or by 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 and, or the Registrar-General shall ensure that appropriate restrictive measures in respect of the marine equipment concerned, such as withdrawal of the product from the Maltese market, are taken without delay.

(16) Where, on completion of the procedure set out in sub-regulations (10) and (11), objections are raised against a measure taken by the Technical Regulations Division and, or the Registrar-General, or where the European Commission considers that a national measure may 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 and shall evaluate the national measure. On the basis of the results of that evaluation, the European Commission shall decide whether or not the relevant national measure is justified. If the relevant national measure is considered justified, the Technical Regulations Division and, or the Registrar-General shall take the measures necessary to ensure that the non-compliant marine equipment is withdrawn from the Maltese market, and, where necessary, recalled. They shall inform the European Commission accordingly.

If the relevant national measure is considered unjustified, the national measure shall be withdrawn.

(17) Where, having performed an evaluation under sub-regulation (5), the Technical Regulations Division and, or the Registrar-General find that marine equipment which is in market, no longer presents that risk, to withdraw the marine equipment from the market or to recall it within such reasonable period, commensurate with the nature of the risk, as it may prescribe.

(18) The economic operator shall ensure that corrective action is taken in respect of all the products concerned that it has made available on the market throughout the Union or placed on board EU ships.

(19) The Technical Regulations Division and, or the Registrar-General shall immediately inform the European Commission and the other Member States. The information provided shall include all available details, in particular the data necessary for the identification of the marine equipment concerned, the origin and the supply chain of the marine equipment, the nature of the risk involved and the nature and duration of the national measures taken.

(20) Without prejudice to sub-regulations (5) to (15), where the Technical Regulations Division and, or the Registrar-General make one of the following findings, they shall require the relevant economic operator to put an end to the non-compliance concerned:

(a) the wheel mark has been affixed in violation of regulations 7 or 8;

(b) the wheel mark has not been affixed;

(c) the EU declaration of conformity has not been drawn up;

(d) the EU declaration of conformity has not been drawn up correctly;

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

(f) the EU declaration of conformity has not been sent to the ship.

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

(20) persists, the Technical Regulations Division and, or the Registrar-General shall take all appropriate measures to restrict or to prohibit the marine equipment being made available on the Maltese market or to ensure that it is recalled or withdrawn from the Maltese market.