The Commission shall be assisted by the Committee on Medical Devices established by Article 114 of Regulation (EU) 2017/745. That committee shall be a committee within the meaning of Regulation (EU) No 182/2011

Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.

Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.

Where the committee delivers no opinion, the Commission shall not adopt the draft implementing act and the third subparagraph of Article 5(4) of Regulation (EU) No 182/2011 shall apply.

Where reference is made to this paragraph, Article 8 of Regulation (EU) No 182/2011, in conjunction with Article 4 or 5 thereof, as appropriate, shall apply.