Medical Devices Ordinance
(MedDO)


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Art. 47 Technical documentation

1 Man­u­fac­tur­ers must list in the tech­nic­al doc­u­ment­a­tion the in­form­a­tionre­quired in An­nexes II and III to EU-MDR86, tak­ing ac­count of the amend­ments to these An­nexes made by the European Com­mis­sion by means of del­eg­ated acts87.

2 Man­u­fac­tur­ers must sub­mit either the com­plete tech­nic­al doc­u­ment­a­tion or a sum­mary of this doc­u­ment­a­tion when re­ques­ted to do so by the com­pet­ent au­thor­ity.

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

87 See An­nex 4.

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