Medical Devices Ordinance (MedDO) (MedDO)
Medical Devices Ordinance (MedDO) (MedDO)
SR 812.213 — Medical Devices Ordinance of 1 July 2020 (MedDO).
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.
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:
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).
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
