CH vs EU MDR vs FDA — Key Differences
Overview
Switzerland is the closest regulatory analog to the EU in global medical device regulation — the differences are primarily procedural (DAPI vs EUDAMED, CH REP vs EU REP) rather than technical. The FDA framework is substantively different.
Comparison Table
| Aspect | Switzerland (MedDO) | European Union (MDR) | USA (FDA 21 CFR) |
|---|---|---|---|
| Regulatory authority | Swissmedic | 27 National Competent Authorities | FDA CDRH |
| Primary legislation | TPA + MedDO (SR 812.213) | EU MDR 2017/745 | FD&C Act |
| Device classification | Class I, IIa, IIb, III (22 rules) | Class I, IIa, IIb, III (22 rules — identical) | Class I, II, III (product code system) |
| IVD classification | List A, B, Self-test, General | Class A, B, C, D | Exempt / 510(k) / PMA |
| Third-party reviewer | EU-designated NB (no Swiss NBs) | EU-designated NB | FDA itself |
| Class III market access | NB assessment + DAPI registration | NB assessment + EUDAMED | PMA (FDA direct review) |
| Conformity marking | CE mark + Swiss registration | CE mark | No CE mark — 510(k) clearance/PMA approval |
| Representative requirement | CH REP (if not in Switzerland) | EU REP (if not in EU) | US Agent (if not in US) |
| Representative liability | Joint and several (Art. 57) | Joint and several (MDR Art. 11) | Administrative only — no joint liability |
| Product database | DAPI (Swissmedic) | EUDAMED | GUDID (FDA) + establishment registration |
| Labelling language | DE, FR, IT mandatory | Language of each EU member state | English (US market) |
| Clinical evidence | Clinical evaluation (MedDO Annex XIV) | Clinical evaluation (MDR Annex XIV — identical) | Substantial equivalence (510k) or full clinical data (PMA) |
| Vigilance reporting | Swissmedic eVigilance | National CA of each EU state | FDA eMDR (21 CFR 803) |
| Post-market surveillance | PMS plan + PSUR (Class IIa+) | PMS plan + PSUR (Class IIa+) | PMS plan; 522 studies (FDA-ordered) |
| QMS standard | ISO 13485 | ISO 13485 | QMSR (21 CFR 820, aligned with ISO 13485 from 2026) |
Key Insight for Multi-Market Submissions
A manufacturer who has completed EU MDR conformity assessment and CE certification has completed the substantive technical work for Swiss market access. The Swiss-specific additions are procedural: appoint CH REP, register in DAPI, prepare Swiss labelling (DE/FR/IT), and establish Swissmedic eVigilance reporting.
Disclaimer
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.