Medical Devices Ordinance
(MedDO)


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Art. 20 Information on implantable devices

1 For im­plant­able products, the man­u­fac­turer must provide, in ad­di­tion to the product in­form­a­tion re­quired un­der Art­icle 16, the in­form­a­tion re­quired un­der Art­icle 18 para­graph 1 EU-MDR51, in­clud­ing the im­plant card. The ex­emp­tions spe­cified un­der Art­icle 18 para­graph 3 EU-MDR ap­ply, tak­ing ac­count of the amend­ments ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts52.

2 The im­plant card must drawn up in all three of­fi­cial lan­guages of Switzer­land.

3 Health­care in­sti­tu­tions must enter the de­tails of the im­plant re­cip­i­ent in the im­plant card and give the card to the re­cip­i­ent. They provide the es­sen­tial in­form­a­tion needed by the re­cip­i­ent in a quickly ac­cess­ible mean.

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

52 See An­nex 4.

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