Article 11
1. The Commission shall be assisted by a committee. 2. The Committee shall advise the Commission on the application of Articles 9 and 10. 3. The Committee may furthermore be consulted by the Commission on any other matter concerning the application of this Regulation. 4. Where reference is made to this Article, Articles 3 and 7 of Decision 1999/468/EC(11) shall apply, having regard to the provisions of Article 8 thereof. 5. The Committee shall adopt its rules of procedure. 6) Council Directive 93/42/EEC of 14 June 1993 on medical devices(12).Article 6 is replaced by the following: