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
Third-party reviewer: EU-designated NB (Switzerland has no designated NBs; EU NBs conduct assessments for Swiss market)
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.
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.