+Article 44 10

Article 44 10

10.   In the event of incidents putting at risk patient safety or information security, the market surveillance authorities may take immediate action and require the manufacturer of the EHR system concerned, its authorised representative and other economic operators, if applicable, to take immediate corrective action.

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