+Artikolu 27 2

Artikolu 27 2

2.   Il-fornituri ta’ sistemi tal-IA meqjusa li huma ta’ riskju għoli f’konformità mal-Artikolu 6 tar-Regolament (UE) 2024/1689 (is-“sistema tal-IA b’riskju għoli”) u li ma jaqgħux fil-kamp ta’ applikazzjoni tar-Regolamenti (UE) 2017/745 jew (UE) 2017/746 lijiddikjaraw l-interoperabbiltà ta’ dawk is-sistemi tal-IA b’riskju għoli mal-komponenti tas-software armonizzati tas-sistemi ta’ EHR għandhom jagħtu prova tal-konformità mar-rekwiżiti essenzjali dwar il-komponent tas-software Ewropew tal-interoperabbiltà Ewropew u l-komponent tas-software Ewropew tar-reġistrazzjoni għas-sistemi ta’ EHR, kif stabbilit fit-Taqsima 2 tal-Anness II għal dan ir-Regolament. L-Artikolu 36 ta’ dan ir-Regolament għandu japplika għal dawk is-sistemi tal-IA ta’ riskju għoli.

1. Ħarsa ġenerali

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1.1 Referenzi

1.2 Rekwiżiti identifikati

1.3 Standards relatati

2. Rekwiżiti identifikati

Rekwiżiti

3. Standards relatati

Standards
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