+Article 36 4

Article 36 4

4.   EHR systems, medical devices, in vitro diagnostic medical devices and high-risk AI systems referred to in Articles 25 and 27 that are in conformity with the common specifications referred to in paragraph 1 of this Article shall be considered to be in conformity with the essential requirements covered by those common specifications or parts thereof, laid down in Annex II, and covered by those common specifications or the relevant parts thereof.

1. Forbhreathnú

,
Teideal Rialáil

1.1 Tagairtí

1.2 Ceanglais aitheanta

1.3 Caighdeáin ghaolmhara

2. Ceanglais aitheanta

Ceanglais
Foinse Ceanglas

3. Caighdeáin ghaolmhara

Caighdeáin
Foinse Ceanglas