- The Commission shall be assisted by a Committee on Medical Devices. 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 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.
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.
