Hospital Exemption
Overview
The hospital exemption permits licensed healthcare institutions to manufacture devices in-house for use exclusively within that institution, without standard MedDO conformity assessment and DAPI registration. Legal basis: TPA Art. 9 para. 2(a) and MedDO Art. 37.
Conditions to Qualify
- The institution is a licensed Swiss healthcare institution
- The device is manufactured exclusively for use within the institution (no sale or transfer elsewhere)
- No registered equivalent device is available on the Swiss market
- The device meets applicable General Safety and Performance Requirements
- An appropriate QMS is implemented for the manufacturing activities
- Swissmedic is notified before the device is first put into use
Scope Limitations
The exemption does NOT cover: devices manufactured for sale or transfer to other institutions; devices for which a registered equivalent exists; sterile implantable devices manufactured in-house.
Swissmedic Notification
The institution must notify Swissmedic before first use, providing: device description and intended purpose; justification that no registered equivalent exists; confirmation of QMS implementation. Swissmedic may inspect to verify compliance.
Official Sources
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.