Glossary of Key Terms
DAPI Swissmedic's product database of authorised therapeutic products and devices. Manufacturers and CH REPs register or notify medical devices through DAPI at dapi.ch before market placement in Switzerland.
Official Sources
Content is AI-assisted and intended as a navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.
NB Notified Body. EU-designated third-party conformity assessment body. Switzerland uses EU NBs — there are no Swiss-designated NBs.'
To: 'NB Notified Body. EU-designated third-party conformity assessment body accredited for medical device conformity assessment under EU MDR/IVDR. Switzerland recognises EU NBs for device assessment; there are no separate Swiss-designated NBs. NB audit findings and reports are submitted to Swissmedic as part of the DAPI registration process.'
'DAPI Registration The process by which a manufacturer or CH REP formally registers a medical device in Swissmedic's DAPI database before market placement, including submission of conformity assessment documentation, technical file summary, and applicable fees.'
'DAPI Notification The simplified registration process for lower-risk devices (typically Class I non-sterile non-measuring devices) where the manufacturer or CH REP provides basic device information to DAPI without full technical file submission.