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Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ) article 95 CELEX: 02017R0746-20250110 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 88(4); (b) the final inspection report as referred to in Article 88(7); (c) information in relation to devices presenting an unacceptable risk to health and safety as referred to in Article 90(2), (4) and (6); (d) information in relation to non-compliance of products as referred to in Article 92(2); (e) information in relation to the preventive health protection measures referred to in Article 93(2); (f) summaries of the results of the reviews and assessments of the market surveillance activities of the Member States referred to in Article 88(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 51 for the device concerned and be accessible to the Member States and to the Commission. |
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance. ) article 95 CELEX: 02017R0746-20250110 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. |