English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 72 Data processing in general
The provisions of Chapter 10 of MedDO, with the exception of Article 90 MedDO, apply mutatis mutandis to data process by Swissmedic and third parties contracted by Swissmedic.
SR 812.213
Art. 73 Publication of data
Swissmedic may publish the following in the medical devices information system: a. device data, as specified in Part B of Annex VI to EU-IVDR; b. information on economic operators and devices, as specified in Part A of Annex VI to EU-IVDR; c. the general information specified in Article 31 paragraph 7 EU-IVDR governing the assessment, designation and notification of conformity assessment bodies and for the monitoring of designated bodies, and on changes that have a significant impact on such tasks; d. summaries of the annual report on monitoring and on-site assessment activities drawn up in accordance with Article 40 paragraph 12 EU-IVDR; e. summaries of safety and performance in accordance with Article 56; f. information on certificates issued under Articles 24 and 35–37; g. field safety notices for users or customers issued in the course of field safety corrective actions in accordance with Article 84 paragraph 8 EU-IVDR; h. summaries of the reports on Swissmedic's activities in moni
let. a — See the footnote to Art. 4 para. 1 let. e.
