Medical Devices Ordinance
(MedDO)


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Art. 46 Affixing the conformity marking and clinical evaluation

1 Man­u­fac­tur­ers guar­an­tee that their devices have been de­signed and man­u­fac­tured in ac­cord­ance with the re­quire­ments of this Or­din­ance when they place them on the mar­ket or put them in­to ser­vice.

2 They must af­fix the con­form­ity mark­ing to their devices.

3 They must con­duct a clin­ic­al eval­u­ation in ac­cord­ance with Art­icle 61 EU-MDR82 tak­ing ac­count of the amend­ments to this Art­icle ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts83 and in ac­cord­ance with An­nex XIV to EU-MDR. They must up­date this clin­ic­al eval­u­ation in line with the res­ults of post-mar­ket clin­ic­al fol­low-up.

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

83 See An­nex 4.

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