:INFO [align:center, links:https://fedlex.data.admin.ch/eli/cc/2020/552] Medical Devices Ordinance (MedDO) (MedDO) SR 812.213 — Medical Devices Ordinance of 1 July 2020 (MedDO). | :NOTE [links:https://fedlex.data.admin.ch/eli/cc/2020/552] English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force. This English text is the consolidation of 1 November 2023. The binding German, French and Italian texts have since been consolidated to 1 July 2026, so this translation is behind current law. :INFO Preamble The Swiss Federal Council, based on the Therapeutic Products Act of 15 December 2000 (TPA), Article 21 number 2 of the Electricity Act of 24 June 1902, Article 5 of the Metrology Act of 17 June 2011, Article 4 paragraph 1 of the Federal Act of 12 June 2009 on Product Safety, Article 37 paragraph 1 of the Radiological Protection Act of 22 March 1991 andin implementation of the Federal Act of 6 October 1995 on Technical Barriers to Trade, ordains: | :NOTE SR 812.21 SR 734.0 SR 941.20 SR 930.11 SR 814.50 SR 946.51 Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). :INFO Contents 1. General Provisions — 5 articles 2. Making available on the Market and Putting into Service — 15 articles 3. Conformity Assessment, Certificate and Declaration — 9 articles 4. Requirements applicable to Tissues and Cells of Human Originthat are incorporated into or used in the Production of Devices — 3 articles 5. Designated Bodies — 13 articles 6. Requirements for Economic Operators — 10 articles 7. Device Surveillance — 12 articles 8. Conduct in relation to Devices — 7 articles 9. Market Surveillance — 6 articles 10. Data Processing — 14 articles 11. Final Provisions — 21 articles :LINK https://fedlex.data.admin.ch/filestore/fedlex.data.admin.ch/eli/cc/2020/552/20231101/en/html/fedlex-data-admin-ch-eli-cc-2020-552-20231101-en-html-25.html Official text on Fedlex — consolidation of 1 November 2023