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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. 22Exemptions
1 In response to a justified application, Swissmedic may authorise the placing on the market and putting into service of a specific device the use of which is in the interests of public health or patient safety or health even though:
a.
the relevant conformity assessment procedure according to Article 23 has not been carried out; or
b.
the language requirements in Article 16 paragraph 2 have not been met.
2 Individual devices that have not undergone the relevant conformity assessment procedure may be placed on the market and used without authorisation from Swissmedic provided:
a.
they serve to avert life-threatening conditions or to resolve the permanent impairment of a bodily function;
b.
no conforming device is available for this specific indication;
c.
they are used exclusively by healthcare professionals on individual persons;
d.
the healthcare professional using the device has informed the individual concerned about the non-conformity of the medical device and the related risks; and
e.
the individual concerned has consented to the use of the device.
3 For devices placed on the market exclusively within the armed forces or within the framework of their specific tasks, the Federal Department of Home Affairs (FDHA) may, in agreement with the Federal Department of Defence, Civil Protection and Sports, grant exemptions.