Introduction
Swiss Medical Device Regulatory Reference — plain English guidance for MedDO (SR 812.213), IVDO (SR 812.219), and the Therapeutic Products Act.
| Section | Scope |
|---|---|
| Start Here | Definitions, MedDO vs IVDO, roles, lifecycle, glossary |
| Pre-Market | Classification, GSPRs, tech docs, conformity, Swissmedic registration, clinical evidence |
| Post-Market | Vigilance, PMS, PSUR, FSCA, labelling (DE/FR/IT), UDI, advertising |
| Legislation | TPA, MedDO, IVDO, ClinO-MD, MRA with EU, how to read Swiss law |
| Guidance | Swissmedic guidance index, MDCG applicability, forms |
| What's New | Regulatory changes, MRA updates, consultations, transitional tracker |
| Conformity Assessment Bodies | EU NBs in Switzerland, NANDO, audit process |
| Special Access | Compassionate use, hospital exemption, named-patient |
| Market Surveillance | Swissmedic enforcement, safeguard procedures, cantons |
| Non-Swiss Manufacturer Access | CH REP obligations, MRA impact, CH vs EU vs FDA |
New to Swiss regulation? → What is a Medical Device? Not sure which ordinance applies? → MedDO vs IVDO Non-Swiss manufacturer? → Requirements for Non-Swiss Manufacturers
Disclaimer
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
Regulatory Pathway Map
Click a phase to expand — each card links to the relevant section of this guide.