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+Article 60a 5. |
Article 60a 5.The frameworks for real-world testing shall lay down the requirements under which testing in real-world conditions shall occur. Those frameworks shall:
(a)
include the provision of a mandatory real-world testing plan to be agreed between the provider or prospective provider and the national competent authority or relevant authority in accordance with the Union harmonisation legislation listed in Section B of Annex I;
(b)
ensure compliance with the requirements laid down in Article 60(2), (3), (4)(d)-(j) and (5)-(9), where any reference to market surveillance authorities in those provisions shall be read as a reference to the national competent authority or relevant authority, as appropriate in accordance with the Union harmonisation legislation listed in Section B of Annex I;
(c)
include effective governance and accountability arrangements;
(d)
ensure a high level of protection of health safety and fundamental rights. 1. Übersicht
1.1 Referenzen1.2 Identifizierte Anforderungen1.3 Zugehörige Standards2. Identifizierte Anforderungen
3. Zugehörige Standards
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