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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. 28Documentation requirements
1 The designated body will provide Swissmedic and the other designated bodies with:42
a.
all information on certificates it has issued and any amendments or addenda to such certificates;
b.
information on suspended, reactivated or revoked certificates;
c.
information on certificates it has rejected;
d.
information on restrictions imposed on certificates.
2 It will also provide Swissmedic with information on whether or not a conformity assessment procedure should be applied in accordance with Article 54 paragraph 1 EU-MDR43. Notifications of certificates for devices that have undergone a procedure of this type must include the documents specified in Article 55 paragraph 1 EU-MDR.44
42 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).
43 See the footnote to Art. 4 para. 1 let. f.
44 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).