Definition: Health Legislation on Governance Interoperability (EBI) is a grouping that covers various regulations and directives issued by the European Parliament and the Council. These regulations and directives are primarily focused on medical devices, including in vitro diagnostic medical devices, and their governance and interoperability within the European Economic Area (EEA). Source: EIRA Team Research Additional information: The Health Legislation on Governance Interoperability (EBI) includes key regulations such as Regulation (EU) 2017/746 and Regulation (EU) 2017/745, both issued on 5 April 2017, and Directive 98/79/EC issued on 27 October 1998. These regulations and directives are crucial for the standardization and interoperability of medical devices within the EEA. They provide guidelines for the development, production, and use of these devices, ensuring their safety, effectiveness, and compliance with the relevant EU laws. Example: An example of the application of these regulations can be seen in the production of in vitro diagnostic medical devices. Manufacturers must comply with the guidelines set out in Regulation (EU) 2017/746 and Directive 98/79/EC to ensure their products are safe, effective, and interoperable with other devices within the EEA. LOST view: LV-Architecture Principles Identifier: http://data.europa.eu/dr8/egovera/HealthLegislationOnGovernanceInteroperabilityGrouping ABB name: egovera:HealthLegislationOnGovernanceInteroperabilityGrouping EIRA concept: eira:ArchitectureBuildingBlock Last modification: 2023-08-20 dct:identifier: http://data.europa.eu/dr8/egovera/HealthLegislationOnGovernanceInteroperabilityGrouping dct:title: Health Legislation On Governance Interoperability (EBI)