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Medical Devices Ordinance (MedDO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
of 1 July 2020 (Status as of 26 May 2021)
Art. 18Obligation to report the use of devices manufactured in healthcare institutions
1 Healthcare institutions that manufacture and use devices as specified in Article 9 shall provide the following information to Swissmedic prior to putting the devices into service:
a.
their name and address;
b.
the name and intended purpose of the device;
c.
the risk class of the device in accordance with Article 15 paragraph 1.
2 Any other relevant information about these devices must be submitted to Swissmedic at Swissmedic’s request. The declaration required under Article 5 paragraph 5 letter e EU-MDR31 must be made publicly available.
3 Changes to the information required in paragraph 1 must be reported to Swissmedic within 30 days.
4 Depending on the risk inherent in a device and its use, Swissmedic may exempt devices manufactured and used in accordance with Article 9 from the reporting obligation.