Regulation on the European Health Data Space (EHDS) 30: Meet the manufacturer duties: conformity, documentation, declaration, CE marking, contact details and registration

Article 30(1)(a) to (h), (2) and (3): manufacturers ensure the harmonised components and the system meet Annex II and the common specifications and are not adversely affected by other components; draw up and update technical documentation before placing on the market; supply the information sheet and instructions free; draw up the EU declaration of conformity; affix the CE marking; give a single point of contact in the system; register under Article 49; keep procedures so design and deployment changes stay compliant and are reflected in the documentation; and keep documentation and the declaration for 10 years after placing on the market, providing source code or programming logic to authorities on reasoned request.