contents table Lexparency.org
Medical Device Regulation (MDR)
Article 100

Article 100 — Electronic system on market surveillance

  1. The Commission, in collaboration with the Member States, shall set up and manage an electronic system to collate and process the following information:
    (a)

    summaries of the results of the surveillance activities referred to in Article 93(4);

    (b)

    the final inspection report referred to in Article 93(7);

    (c)

    information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 95(2), (4) and (6);

    (d)

    information in relation to non-compliance of products as referred to in Article 97(2);

    (e)

    information in relation to the preventive health protection measures referred to in Article 98(2);

    (f)

    summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in 93(8).

  2. The information referred to in paragraph 1 of this Article shall be immediately transmitted through the electronic system to all competent authorities concerned and, where applicable, to the notified body that issued a certificate in accordance with Article 56 for the device concerned and be accessible to the Member States and to the Commission.
  3. Information exchanged between Member States shall not be made public where to do so might impair market surveillance activities and co-operation between Member States.