🏥 New CE marking obligations for EHR systems under EHDS Regulation 2025/327
One of the least publicised requirements of the new Regulation 2025/327 on the European Health Data Space is the obligation of CE marking for electronic health record (EHR) systems.
What is an EHR system?
Any software, or combination of hardware and software, that allows personal electronic health data to be stored, intermediated, exported, imported, converted, edited or viewed, intended to be used by healthcare providers or by patients.
Key particularity: it is a self-certification procedure — no Notified Body is involved.
Technical requirements:
The essential requirements are laid down in Annex II of the Regulation, following a scheme similar to that of medical software (MDR). Technical documentation according to Annex III and an EU Declaration of Conformity according to Annex IV (kept for a minimum of 10 years).
Mandatory registration:
Before placing an EHR system on the market or putting it into service, the manufacturer must register in the EU database for EHR systems and wellness applications.
📅 Application timeline:
- Entry into force: 25 March 2025
- Applicable from: 26 March 2027
- EHR systems already in service: 26 March 2031