National requirements and reporting to the Commission

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.

52/96 ELI: http://data.europa.eu/eli/reg/2025/327/oj

SECTION 4 Market surveillance of EHR systems