Products with digital elements shall only be made available on the market where:

(1)they meet the essential requirements set out in Section 1 of Annex I, under the condition that they are properly installed, maintained, used for their intended purpose or under conditions which can reasonably be foreseen, and, where applicable, updated, and

(2)the processes put in place by the manufacturer comply with the essential requirements set out in Section 2 of Annex I.