+Article 49 3

Article 49 3

3.   Medical devices, in vitro diagnostic medical devices or high-risk AI systems referred to in Article 27(1) and (2) of this Regulation shall also be registered in the databases established pursuant to Regulation (EU) 2017/745, (EU) 2017/746 or (EU) 2024/1689, as applicable. In such cases, the data to be entered shall also be forwarded to the EU database for registration of EHR systems and wellness applications.

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