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1. The standards referred to in Article 8(4) of this Directive shall be established in accordance with the procedure provided for in Article 6(3) of Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations and of rules on Information Society services (). The request for developing these standards may be established in consultation with the Committee referred to in Article 21(1).

2. The Commission shall publish the references of the standards in the Official Journal of the European Union.

3. When a Member State or the Commission considers that a harmonised standard does not entirely satisfy the requirements which it covers and which are set out in Annex II, the Commission or the Member State concerned shall bring the matter before the Committee set up by Article 5 of Directive 98/34/EC, giving its arguments. The Committee shall, having consulted the relevant European standardisation bodies, deliver its opinion without delay.

In the light of the Committee’s opinion, the Commission shall decide to publish, not to publish, to publish with restriction, to maintain, to maintain with restriction or to withdraw the references to the harmonised standard concerned in or from the Official Journal of the European Union. The Commission shall inform the European standardisation body concerned and, if necessary, request the revision of the harmonised standards concerned.