EHDS, Artikkel 47, DE
1. Where a manufacturer of a wellness application claims interoperability with an EHR system in relation to the harmonised software components of EHR systems and therefore compliance with the common specifications referred to in Article 36 and essential requirements laid down in Annex II, such wellness application shall be accompanied by a label, clearly indicating its compliance with those specifications and requirements. That label shall be issued by the manufacturer of the wellness application.
2. The label referred to in paragraph 1 shall indicate the following information:
(a)
the categories of electronic health data for which compliance with essential requirements laid down in Annex II has been confirmed;
(b)
a reference to common specifications to demonstrate compliance;
(c)
the validity period of the label.
3. The Commission shall, by means of implementing acts, determine the format and content of the label referred to in paragraph 1. Those implementing acts shall be adopted in accordance with the examination procedure referred to in Article 98(2).
4. The label shall be drawn-up in one or more official languages of the Union or in an easily understandable language determined by the Member State in which the wellness application is placed on the market or put into service.
5. The validity of the label shall not exceed three years.
6. If the wellness application is an integral part of a device or is embedded in a device after it has been put into service, the accompanying label shall be shown in the application itself or placed on that device. Where the wellness application consists only of software, the label shall have a digital format and shall be shown in the application itself. Two-dimensional (2D) barcodes may also be used to display the label.
7. The market surveillance authorities shall check the compliance of wellness applications with the essential requirements laid down in Annex II.
8. Each supplier of a wellness application for which a label has been issued shall ensure that the wellness application that is placed on the market or put into service is accompanied by the label for each individual unit, free of charge.
Versjon: e102dbcafe22c749
SHA-256: sha256:e102dbcafe22c749f194fcc55bfc468e4651dfa454b4f48b392475cf6d3dad22
- Artikkel 1
- Artikkel 2
- Artikkel 3
- Artikkel 4
- Artikkel 5
- Artikkel 6
- Artikkel 7
- Artikkel 8
- Artikkel 9
- Artikkel 10
- Artikkel 11
- Artikkel 12
- Artikkel 13
- Artikkel 14
- Artikkel 15
- Artikkel 16
- Artikkel 17
- Artikkel 18
- Artikkel 19
- Artikkel 20
- Artikkel 21
- Artikkel 22
- Artikkel 23
- Artikkel 24
- Artikkel 25
- Artikkel 26
- Artikkel 27
- Artikkel 28
- Artikkel 29
- Artikkel 30
- Artikkel 31
- Artikkel 32
- Artikkel 33
- Artikkel 34
- Artikkel 35
- Artikkel 36
- Artikkel 37
- Artikkel 38
- Artikkel 39
- Artikkel 40
- Artikkel 41
- Artikkel 42
- Artikkel 43
- Artikkel 44
- Artikkel 45
- Artikkel 46
- Artikkel 48
- Artikkel 49
- Artikkel 50
- Artikkel 51
- Artikkel 52
- Artikkel 53
- Artikkel 54
- Artikkel 55
- Artikkel 56
- Artikkel 57
- Artikkel 58
- Artikkel 59
- Artikkel 60
- Artikkel 61
- Artikkel 62
- Artikkel 63
- Artikkel 64
- Artikkel 65
- Artikkel 66
- Artikkel 67
- Artikkel 68
- Artikkel 69
- Artikkel 70
- Artikkel 71
- Artikkel 72
- Artikkel 73
- Artikkel 74
- Artikkel 75
- Artikkel 76
- Artikkel 77
- Artikkel 78
- Artikkel 79
- Artikkel 80
- Artikkel 81
- Artikkel 82
- Artikkel 83
- Artikkel 84
- Artikkel 85
- Artikkel 86
- Artikkel 87
- Artikkel 88
- Artikkel 89
- Artikkel 90
- Artikkel 91
- Artikkel 92
- Artikkel 93
- Artikkel 94
- Artikkel 95
- Artikkel 96
- Artikkel 97
- Artikkel 98
- Artikkel 99
- Artikkel 100
- Artikkel 101
- Artikkel 102
- Artikkel 103
- Artikkel 104
- Artikkel 105
Source: NovaCopilot