IvDO
SR 812.219 — Ordinance of 26 May 2022 on In Vitro Diagnostic Medical Devices (IvDO) of 4 May 2022.
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force. English consolidation of 1 July 2026, which is also the date of the current binding text.
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
Contents
1. General provisions — 5 articles 2. Making available on the Market and Putting into Service — 11 articles 3. Conformity Assessment, Certificate and Declaration — 9 articles 4. Designated Bodies — 13 articles 5. Requirements for Economic Operators — 10 articles 6. Device Surveillance — 12 articles 7. Conduct in relation to Devices — 5 articles 8. Market Surveillance — 6 articles 9. Data Processing — 2 articles 10. Final Provisions — 18 articles
