European Health Data Space Representative (EHDS)

The EHDS Representative is a mandatory legal entity or person established in the EU, mandated by a non-EU manufacturer. This role is crucial for ensuring that your digital health products meet the stringent requirements for safety, security, and interoperability set by the EHDS Regulation.

Your representative acts as a critical liaison with EU authorities, including:

• Market surveillance authorities: The representative is the main contact point for all conformity assessment and post-market surveillance activities.
• Competent authorities: They cooperate with national bodies on all matters related to the EHDS Regulation.
• Users and consumers: They serve as a contact point for any inquiries or complaints from professional users and patients in the EU.

The EHDS Regulation primarily applies to manufacturers of Electronic Health Record (EHR) systems that are placed on the EU market. If your company develops and sells software or hardware designed to process and store personal health data for the provision of healthcare, and you are not based in the EU, then you are required to appoint a representative.

This includes systems that handle:

• Patient summaries and e-prescriptions
• Medical imaging and reports
• Laboratory test results
• Discharge reports

Failure to appoint an EHDS Representative could result in significant penalties and the inability to legally sell your products in the EU, as it is a precondition for a Declaration of Conformity and affixing the CE marking.