+Artikolu 27 1

Artikolu 27 1

1.   Il-manifatturi ta’ apparati mediċi jew apparati mediċi dijanjostiċi in vitro, kif definit fl-Artikolu 2, il-punt (1) tar-Regolament (UE) 2017/745 u l-Artikolu 2 il-punt (2) tar-Regolament (UE) 2017/746, rispettivament, li jiddikjaraw l-interoperabbiltà ta’ dawk l-apparati mediċi jew tagħmir mediku ta’ diagnostika in vitro 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 u l-komponent tas-software Ewropew tar-reġistrazzjoni għas-sistemi ta’ EHR, stabbiliti fit-Taqsima 2 tal-Anness II għal dan ir-Regolament. L-Artikolu 36 ta’ dan ir-Regolament għandu japplika għal dak l-apparat mediku u t-tagħmir mediku ta’ diagnostika in vitro.

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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