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)


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Art. 38 Duty of cooperation and notification requirement

1 The des­ig­nated bod­ies, in­clud­ing their sub­si­di­ar­ies and sub-con­tract­ors, are re­quired to keep avail­able for Swiss­med­ic at all times all data that is ne­ces­sary for as­sess­ment, des­ig­na­tion, mon­it­or­ing and re-as­sess­ment, in­clud­ing the doc­u­ments re­quired to as­sess the qual­i­fic­a­tions of sub-con­tract­ors or sub­si­di­ar­ies. The data must be kept up-to-date at all times.

2 The des­ig­nated bod­ies shall no­ti­fy Swiss­med­ic with­in 15 days of any change that af­fects their abil­ity to meet the re­quire­ments of An­nex VII to EU-MDR54 or to carry out con­form­ity as­sess­ments.

54 See the foot­note to Art. 4 para. 1 let. f.

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