S.L. 427.99 Art. 8Non-compliance interoperability constituents with essential requirements.

(1) Where the Technical Regulations Division finds of that an interoperability constituent covered by the ‘EC’ declaration of conformity or suitability for use and placed on the market is, when used as intended, unlikely to meet the essential requirements, the Technical Regulations Division shall take all necessary steps to restrict its field of application, prohibit its use, withdraw it from the market or recall it. The Technical Regulations Division shall forthwith inform the Commission, the Agency and the other Member States of the measures taken and give reasons for its decision, stating in particular whether the failure to conform is due to:

(a) failure to meet the essential requirements;

(b) incorrect application of European specifications where application of such specifications is relied upon;

(c) inadequacy of European specifications.

(2) Where the decision referred to in sub-regulation 1 results from an inadequacy of European specifications, the Technical Regulations Division, the Commission or the Agency, as appropriate, shall apply one or more of the following measures:

(a) partial or total withdrawal of the specification concerned from the publications containing them;

(b) if the relevant specification is a harmonised standard, restriction or withdrawal of that standard in accordance with Article 11 of Regulation (EU) No 1025/2012;

(c) review of the TSI in accordance with Article 6 of Directive (EU) 2016/797.

(3) Where an interoperability constituent bearing the ‘EC’ declaration of conformity fails to comply with the essential requirements, the Technical Regulations Division shall take appropriate measures against any entity which has drawn up the declaration and shall inform the Commission and the other Member States thereof.