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EU regulatory register · EHDS

Article 42National requirements and reporting to the Commission

CELEX 32025R0327 · Read on 2026-08-31

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1. Member States may adopt national requirements for EHR systems and provisions on their conformity assessment in relation to aspects other than the harmonised software components of EHR systems.

Verbatim from the article. Source: NovaCopilot · https://legal.exploreworldai.com/eu/rattsakter/helsodata-2025-327/artikel-42 · Short answer as data · Official text

Official text

Read from the EU Publications Office for this CELEX number. The wording stands as published; nothing here is rewritten or summarised.

1. Member States may adopt national requirements for EHR systems and provisions on their conformity assessment in relation to aspects other than the harmonised software components of EHR systems.

2. The national requirements or provisions referred to in paragraph 1 shall not adversely affect the harmonised software components of EHR systems.

3. When Member States adopt requirements or provisions in accordance with paragraph 1, they shall inform the Commission thereof.

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