+Article 33 4

Article 33 4

4.   Distributors shall, further to a reasoned request from a market surveillance authority, provide it with all the information and documentation necessary to demonstrate the conformity of an EHR system. They shall cooperate with that authority, at its request, and with the manufacturer, the importer and, where applicable, with the manufacturer’s authorised representative on any action taken to bring an EHR system into conformity with the essential requirements laid down in Annex II and with any requirements adopted pursuant to Article 42 or to recall or withdraw it.

1. Prehľad

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Názov Regulácia

1.1 Odkazy

1.2 Identifikované požiadavky

1.3 Súvisiace štandardy

2. Identifikované požiadavky

Požiadavky
Zdroj Požiadavka

3. Súvisiace štandardy

Štandardy
Zdroj Požiadavka