S.L. 454.2 Art. 35Procedure for dealing with instruments presenting a risk at national level.

(1) Where the Authority has sufficient reason to believe that an instrument covered by these regulations presents a risk to aspects of public interest protection covered by these regulations, it shall carry out an evaluation in relation to the instrument concerned covering all relevant requirements laid down in these regulations. The relevant economic operators shall cooperate as necessary with the Authority for that purpose. Where, in the course of the evaluation referred to above, the Authority finds that the instrument does not comply with the requirements laid down in these regulations, it shall without delay require the relevant economic operator to take all appropriate corrective actions to bring the instrument into compliance with those requirements, to withdraw the instrument from the market, or to recall it within a reasonable period, commensurate with the nature of the risk, as they may prescribe. The Authority shall inform the relevant notified body accordingly. Article 21 of Regulation (EC) No 765/2008 shall apply to the measures referred to in this regulation.

(2) Where the Authority considers that non-compliance is not restricted to Malta, 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.

(4) Where the relevant economic operator does not take adequate corrective action within the period referred to in sub-regulation (1), the Authority shall take all appropriate provisional measures to prohibit or restrict the instrument’s being made available on their national market, to withdraw the instrument from that market or to recall it. The Authority shall inform the Commission and the other Member States, without delay, of those measures.

(5) All information shall include all available details, in particular the data necessary for the identification of the non-compliant instrument, the origin of the instrument, 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 Authority shall indicate whether the non- compliance is due to either of the following:

(a) failure of the instrument to meet requirements relating to the aspects of public interest protection laid down in these regulations; or

(b) shortcomings in the harmonised standards referred to in regulation 13 conferring a presumption of conformity.

(6) Member States other than the Member State initiating the procedure under this regulation shall without delay inform the 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 instrument concerned, and, in the event of disagreement with the adopted national measure, of their objections.

(7) Where, within three months of receipt of the information, no objection has been raised by either a Member State or the Commission in respect of a provisional measure taken by the Authority, that measure shall be deemed justified.

(8) The Authority shall ensure that appropriate restrictive measures, such as withdrawal of the instrument from the market, are taken in respect of the instrument concerned without delay.