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    Full text of EU MDR (Medical Device Regulation)
    EU MDR Chapter 10 Article 114

    Article 114 – Committee procedure

    1. 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.
    2. Where reference is made to this paragraph, Article 4 of Regulation (EU) No 182/2011 shall apply.
    3. Where reference is made to this paragraph, Article 5 of Regulation (EU) No 182/2011 shall apply.
    4. 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.

    5. 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.
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