Hospital Exemption
Overview
The hospital exemption permits licensed healthcare institutions to manufacture devices in-house for use exclusively within that institution, without stSwiss undergoing procedures or However, devices must still meet General Safety and Performance Requirements, and Swissmedic notification is mandatory before use.ard 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.
Swissmedic typically reviews the notification within 30 days. If the institution fails to meet exemption conditions or Swissmedic identifies compliance gaps during inspection, the exemption may be withdrawn. The institution must immediately cease in-house manufacturing and cease use of non-compliant devices. Regular compliance monitoring by Swissmedic may be required.