Conformity Assessment Bodies
Switzerland has no Swiss-designated notified bodies for medical devices. Manufacturers use EU-designated NBs.
| Page | Covers |
|---|---|
| What Conformity Assessment Bodies Do | NB functions, QMS audits, technical documentation review, unannounced audits |
| EU NBs for the Swiss Market | How EU NBs are used; certificate scope; MRA impact |
| How to Choose a Notified Body | NANDO, capacity, scope, Swiss experience, audit language |
| Audit Process and Timelines | QMS surveillance cycle, unannounced audit obligations, design examination |
| NANDO Database | How to search NANDO; scope verification; designation status |
Disclaimer
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.