S.L. 427.64 Art. 10Withdrawal and prohibition from market.

(1) Where it is ascertained that a product bearing the CE marking referred to in regulation 5 and used in accordance with its intended use does not comply with all the relevant provisions of the applicable implementing measure, the manufacturer or its authorised representative shall be obliged to make the product comply with the provisions of the applicable implementing measure or with the CE marking and to end the infringement under conditions imposed by the Director of Market Surveillance.

(2) Where there is sufficient evidence that a product might be non-compliant, the Director of Market Surveillance shall take the necessary measures which, depending on the gravity of the non-compliance, can go as far as the prohibition of the placing on the market of the product until compliance is established.

(3) Where non-compliance continues, the Director of Market Surveillance shall take a decision restricting or prohibiting the placing on the market or putting into service of the product in question or ensure that it is withdrawn from the market.

(4) (a) Any decision by the Director of Market Surveillance pursuant to these regulations which restricts or prohibits the placing on the market or putting into service of a product shall state the exact grounds on which it is based and the Director of Market Surveillance shall so inform the Directorate thereof.

(b) The Director of Market Surveillance shall forthwith notify the decision to the party concerned, who shall at the same time be informed of the legal remedies available under the laws in force in Malta concerned and of the time limits to which such remedies are subject.

(5) The Director of Market Surveillance shall immediately inform the Directorate of any decision taken pursuant to regulation 10(1), and in particular, whether non-compliance is due to:

(a) failure to satisfy the requirements of the applicable implementing measure;

(b) incorrect application of harmonised standards;

(c) shortcomings in the harmonised standards.

(6) The Directorate shall immediately inform the Commission of any measures taken in pursuance of subregulations (1) to (5).