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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. |