Any device which, when placed on the market or put into service, incorporates as an integral part an in vitro diagnostic medical device as defined in point 2 of Article 2 of Regulation (EU) 2017/746, shall be governed by this Regulation.
Aon fheiste ina n-ionchorpraítear feiste leighis diagnóiseach in vitro mar chuid dhílis di de réir mar a shainmhínítear i bpointe 2 d'Airteagal 2 de Rialachán (AE) 2017/746 nuair a chuirtear ar an margadh nó nuair a chuirtear i seirbhís í, beidh sí faoi réir an Rialacháin seo.