EHDS Conformity Assessment
EHDS conformity assessment is a self-declaration route, not an MDR-style notified body pathway. The deliverable set an EU EHR, medical device or wellness vendor has to produce is fixed: technical documentation, an EU declaration of conformity and an information sheet. The EUR 20 million fine ceiling sits in the secondary-use chapter rather than the conformity chapter, and Article 26(2) defers the real Chapter III deadline to 2031 for SaaS and in-house EHR systems.