Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down... (32021R2078)
INHALT
Commission Implementing Regulation (EU) 2021/2078 of 26 November 2021 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)
- COMMISSION IMPLEMENTING REGULATION (EU) 2021/2078
- of 26 November 2021
- laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards the European Database on Medical Devices (Eudamed)
- Article 1
- Definitions
- Article 2
- Modes of access
- Article 3
- Registration in Eudamed and access to Eudamed via the restricted website
- Article 4
- Nomenclature
- Article 5
- Technical and administrative support
- Article 6
- Ownership and processing of personal data
- Article 7
- Functioning rules
- Article 8
- Malfunction
- Article 9
- Websites for testing and training purposes
- Article 10
- IT Security
- Article 11
- Fraudulent user activity within Eudamed
- Article 12
- Entry into force
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