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IvDO
SR 812.219 — Ordinance of 26 May 2022 on In Vitro Diagnostic Medical Devices (IvDO) of 4 May 2022.
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:NOTE [links:https://fedlex.data.admin.ch/eli/cc/2022/291]
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.

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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:
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:NOTE
SR 812.21
SR 734.0
SR 941.20
SR 930.11
SR 814.50
SR 946.51

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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

:LINK
https://fedlex.data.admin.ch/filestore/fedlex.data.admin.ch/eli/cc/2022/291/20260701/en/html/fedlex-data-admin-ch-eli-cc-2022-291-20260701-en-html.html
Official text on Fedlex — consolidation of 1 July 2026