Full text of EU MDR (Medical Device Regulation)
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EU MDR Chapter 4 Article 48

Article 48 – Peer review and exchange of experience between authorities responsible for notified bodies

  1. The Commission shall provide for the organisation of exchange of experience and coordination of administrative practice between the authorities responsible for notified bodies. Such exchange shall cover elements including:
    1. development of best practice documents relating to the activities of the authorities responsible for notified bodies;
    2. development of guidance documents for notified bodies in relation to the implementation of this Regulation;
    3. training and qualification of the experts referred to in Article 40;
    4. monitoring of trends relating to changes to notified body designations and notifications and trends in certificate withdrawals and transfers between notified bodies;
    5. monitoring of the application and applicability of scope codes referred to in Article 42(13);
    6. development of a mechanism for peer reviews between authorities and the Commission;
    7. methods of communication to the public on the monitoring and surveillance activities of authorities and the Commission on notified bodies.
  2. The authorities responsible for notified bodies shall participate in a peer review every third year through the mechanism developed pursuant to paragraph 1 of this Article. Such reviews shall normally be conducted in parallel with the on-site joint assessments described in Article 39. Alternatively, an authority may make the choice of having such reviews take place as part of its monitoring activities referred to in Article 44.
  3. The Commission shall participate in the organisation and provide support to the implementation of the peer review mechanism.
  4. The Commission shall compile an annual summary report of the peer review activities, which shall be made publicly available.
  5. The Commission may, by means of implementing acts, adopt measures setting out the detailed arrangements and related documents for the peer review mechanism and training and qualification as referred to in paragraph 1 of this Article. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 114(3).


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