Article 35
Identification of economic operators
Economic operators shall, on request, identify the following to the market surveillance authorities, for 10 years from the date when the last EHR system covered by the EU declaration of conformity has been placed on the market:
(a) any economic operator that has supplied them with an EHR system; and
(b) any economic operator to which they have supplied an EHR system.
SECTION 3 Conformity of the harmonised software components of EHR systems
