Skip to main content

Hospital Exemption

Overview​

The hospital exemption permits licensed healthcare institutions to manufacture devices in-house for use exclusively within that institution, without undergoing standard MedDO conformity assessment and DAPI registration. However, devices must still meet General Safety and Performance Requirements, and Swissmedic notification is mandatory before use. 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; 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.