+SECTION 2 Obligations of economic operators with regard to EHR systems
---+Article 30 Obligations of manufacturers of EHR systems
------+Article 30 1
------+Article 30 2
------+Article 30 3
------+Article 30 4
------+Article 30 5
---+Article 31 Authorised representatives
------+Article 31 1
------+Article 31 2
------+Article 31 3
------+Article 31 4
---+Article 32 Obligations of importers
------+Article 32 1
------+Article 32 2
------+Article 32 3
------+Article 32 4
------+Article 32 5
------+Article 32 6
------+Article 32 7
------+Article 32 8
------+Article 32 9
---+Article 33 Obligations of distributors
------+Article 33 1
------+Article 33 2
------+Article 33 3
------+Article 33 4
---+Article 34 Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals
------+Article 34 (a)
------+Article 34 (b)
------+Article 34 (c)
---+Article 35 Identification of economic operators
------+Article 35 (a)
------+Article 35 (b)

SECTION 2 Obligations of economic operators with regard to EHR systems

SECTION 2 Obligations of economic operators with regard to EHR systems

1. Prezentare generală

,
Article 30 Obligations of manufacturers of EHR systems
Article 31 Authorised representatives
Article 32 Obligations of importers
Article 33 Obligations of distributors
Article 34 Cases in which obligations of manufacturers of an EHR system apply to other entities or individuals

An importer, distributor or user shall be considered a manufacturer for the purposes of this Regulation and shall be subject to the obligations laid down in Article 30 where they:
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:

1.1 Referințe

1.2 Cerințe identificate

1.3 Standarde asociate

2. Cerințe identificate

Cerințe

3. Standarde asociate

Standarde