SECTION 1: SCOPE AND GENERAL PROVISIONS FOR EHR SYSTEMS |
Harmonised software components of EHR systems |
Placing on the market and putting into service |
Relation to Union law governing medical devices, in vitro diagnostic medical devices
and AI systems |
Claims |
Procurement, reimbursement and financing |
SECTION 2: OBLIGATIONS OF ECONOMIC OPERATORS WITH REGARD TO EHR SYSTEMS |
Obligations of manufacturers of EHR systems |
Authorised representatives |
Obligations of importers |
Obligations of distributors |
Cases in which obligations of manufacturers of an EHR system apply
to other entities or individuals |
Identification of economic operators |
SECTION 3: CONFORMITY OF THE HARMONISED SOFTWARE COMPONENTS OF EHR SYSTEMS |
Common specifications |
Technical documentation |
Information sheet accompanying the EHR system |
EU declaration of conformity |
European digital testing environment |
CE marking of conformity |
National requirements and reporting to the Commission |
SECTION 4: MARKET SURVEILLANCE OF EHR SYSTEMS |
Market surveillance authorities |
Handling of risks posed by EHR systems and of serious incidents |
Handling of non-compliance |
Union safeguard procedure |
SECTION 5: OTHER PROVISIONS ON INTEROPERABILITY |
Labelling of wellness applications |
Interoperability of wellness applications with EHR systems |
SECTION 6: REGISTRATION OF EHR SYSTEMS AND WELLNESS APPLICATIONS |
EU database for registration of EHR systems and wellness applications |