Switzerland medical device regulations
Official sources linkedSwissmedic rules and guidance for medical device market access, registration, and lifecycle compliance. Each code opens a metadata page with the official source and readable HTML when available.
| Code | Regulation | Category | Effective | Provenance |
|---|---|---|---|---|
| IvDO (SR 812.219) | Ordinance on In Vitro Diagnostic Medical Devices Current Fedlex classified compilation of SR 812.219, applicable from 1 July 2026. ELI work is cc/2022/291, not the previous metadata URL cc/2022/292. Authentic DE/FR/IT plus unofficial EN translation. | General | May 26, 2022 | Official |
| ClinO-MD (SR 810.306) | Ordinance on Clinical Trials with Medical Devices Current Fedlex classified compilation of SR 810.306, applicable from 20 May 2025 — the newest ClinO-MD consolidation per Fedlex SPARQL, re-verified 29 August 2026 with byte-identical expressions. ELI work is cc/2020/553, not the previous metadata URL cc/2020/554. | Clinical Trials | May 26, 2021 | Official |
| MedDO Article 26 | Conformity Certificates and Validity Section view of MedDO certificate validity (Art. 26). Certificates are valid for a maximum of five years. | GMP/QMS | May 26, 2021 | Official |
| MedDO Article 66 | Materiovigilance and Incident Reporting Section view of MedDO incident reporting (Art. 57 and Art. 66). The Swissmedic FSCA page is not the ordinance text. | Vigilance | May 26, 2021 | Official |
| MedDO (SR 812.213) | Medical Devices Ordinance Current Fedlex classified compilation of SR 812.213, applicable from 1 July 2026. ELI work cc/2020/552. Authentic DE/FR/IT plus unofficial EN translation. | Registration | May 26, 2021 | Official |
| MedDO Article 15 | Medical Device Classification Rules Section view of MedDO classification (Art. 15). Devices are divided into classes I, IIa, IIb and III. The previous metadata fragment #art_16 is product information, not classification. | Classification | May 26, 2021 | Official |
| MedDO Swiss Rep Requirements | Swiss Authorized Representative Requirements Section view of MedDO authorised-representative obligations. The Swissmedic CH-REP page remains a collection page; the binding text is MedDO. | Registration | May 26, 2021 | Official |
| TPA (SR 812.21) | Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act) Current Fedlex classified compilation of SR 812.21, applicable 1 January 2025 through 31 December 2026 — Fedlex itself declares this consolidation's applicability window as ending 31 December 2026, and re-fetching all language expressions on 29 August 2026 was byte-identical. German, French, and Italian are equally authentic; the English expression is an unofficial translation. ELI work cc/2001/422. The 1 January 2027 consolidation exists but is not yet applicable. | General | January 1, 2002 | Official |
| IvDO Amendment 2025 | Amended Ordinance on In Vitro Diagnostic Medical Devices Swissmedic collection/news page describing IVD transition changes. Those amendments are in the current IvDO consolidation (ch-ivdo), not a separate Fedlex instrument. | General | — | Official |
| swissdamed | Swiss Database on Medical Devices Swissmedic database portal, not a Fedlex instrument. Not ingested. | Registration | — | Official |
Exports carry source + retrieval dateWhat these codes are
Each row above represents one regulatory instrument. Its code is the authority’s identifier. A regulation page collects the metadata and official source; when readable HTML is available, article links can open and highlight the exact cited passage.
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