Article 60a 5.

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;

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;

include effective governance and accountability arrangements;

ensure a high level of protection of health safety and fundamental rights.