Article 104 (3)
in Article 32, the following paragraph is inserted:
‘5a. Manufacturers of products with digital elements that are classified as EHR systems under Regulation (EU) 2025/327 of the European Parliament and of the Council (*1) shall demonstrate conformity with the essential requirements set out in Annex I to this Regulation using the relevant conformity assessment procedure provided for in Chapter III of Regulation (EU) 2025/327.
(*1) Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data Space and amending Directive 2011/24/EU and Regulation (EU) 2024/2847 (OJ L, 2025/327, 5.3.2025, ELI: http://data.europa.eu/eli/reg/2025/327/oj).’."
1. Vue d’ensemble
| Intitulé |
Réglementation |
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1.1 Références
1.2 Exigences identifiées
1.3 Normes associées
2. Exigences identifiées
Exigences
| Source |
Exigence |
3. Normes associées
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