MDR – Article 100 – Electronic system on market surveillance

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 inArticle 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.

MDR – Article 93 – Market surveillance activities

Article 93

Market surveillance activities

1. The competent authorities shall perform appropriate checks on the conformity characteristics and performance of devices including, where appropriate, a review of documentation and physical or laboratory checks on the basis of adequate samples. The competent authorities shall, in particular, take account of established principles regarding risk assessment and risk management, vigilance data and complaints.

2. The competent authorities shall draw up annual surveillance activity plans and allocate a sufficient number of material and competent human resources in order to carry out those activities taking into account the European market surveillance programme developed by the MDCG pursuant to Article 105 and local circumstances.

3. In order to fulfil the obligations laid down in paragraph 1, the competent authorities:

(a)may require economic operators to, inter alia, make available the
documentation and information necessary for the purpose of
carrying out the authorities’ activities and, where justified, to
provide the necessary samples of devices or access to devices free
of charge; and
(b)shall carry out both announced and, if necessary, unannounced
inspections of the premises of economic operators, as well as
suppliers and/or subcontractors, and, where necessary, at the
facilities of professional users.

4. The competent authorities shall prepare an annual summary of the results of their surveillance activities and make it accessible to other competent authorities by means of the electronic system referred to in Article 100.

5. The competent authorities may confiscate, destroy or otherwise render inoperable devices that present an unacceptable risk or falsified devices where they deem it necessary to do so in the interests of the protection of public health.

6. Following each inspection carried out for the purposes referred to in paragraph 1, the competent authority shall draw up a report on the findings of the inspection that concern compliance with the legal and technical requirements applicable under this Regulation. The report shall set out any corrective actions needed.

7. The competent authority which carried out the inspection shall communicate the content of the report referred to in paragraph 6 of this Article to the economic operator that has been the subject of the inspection. Before adopting the final report, the competent authority shall give that economic operator the opportunity to submit comments. That final inspection report shall be entered in the electronic system provided for in Article 100.

8. The Member States shall review and assess the functioning of their market surveillance activities. Such reviews and assessments shall be carried out at least every four years and the results thereof shall be communicated to the other Member States and the Commission. Each Member State shall make a summary of the results accessible to the public by means of the electronic system referred to in Article 100.

9. The competent authorities of the Member States shall coordinate their market surveillance activities, cooperate with each other and share with each other and with the Commission the results thereof, to provide for a harmonised and high level of market surveillance in all Member States.

Where appropriate, the competent authorities of the Member States shall agree on work-sharing, joint market surveillance activities and specialisation.

10. Where more than one authority in a Member State is responsible for market surveillance and external border controls, those authorities shall cooperate with each other, by sharing information relevant to their role and functions.

11. Where appropriate, the competent authorities of the Member States shall cooperate with the competent authorities of third countries with a view to exchanging information and technical support and promoting activities relating to market surveillance.