+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. Overview

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Summary Regulation

1.1 References

1.2 Identified Requirements

1.3 Related Standards

2. Identified Requirements

Requirements
Source Requirement

3. Related Standards

Standards
Source Requirement