Definition: The use or consumption of feature provided by a medical devices system (MDS). A MDS enables health professionals and health control agencies to manage the registries of medical devices which can be prescribed to patients.
Source: Healthcare Information and Management Systems Society (HIMSS)
Source reference: https://www.himss.org/library/medical-devices-system-mds
Additional information: The Medical Devices System (MDS) is a comprehensive digital service that encompasses a wide range of functions. It includes the registration of medical devices, tracking of adverse events, post-market surveillance, and risk management. The system is designed to facilitate the exchange of information between manufacturers, healthcare providers, regulators, and patients. It provides a centralized platform for the reporting, analysis, and dissemination of data related to medical devices. This includes data on device performance, adverse events, recalls, and patient outcomes. The MDS also supports the development and implementation of regulatory standards and guidelines for medical devices.
Example: Examples of the application of the Medical Devices System (MDS) include: 1) A manufacturer registering a new medical device in the system, providing all necessary documentation and data for regulatory approval. 2) A healthcare provider reporting an adverse event related to a medical device, which is then tracked and analyzed by the system. 3) A regulator using the system to monitor the post-market performance of a medical device, identifying any potential safety issues and taking appropriate action. 4) A patient accessing information about a medical device, including its safety record and any recalls or warnings.
LOST view: TVA-Health Patient Summary Enablers [Motivation]
Identifier: http://data.europa.eu/dr8/egovera/MedicalDevicesSystemApplicationService
EIRA traceability: eira:DigitalSolutionApplicationService
ABB name: egovera:MedicalDevicesSystemApplicationService
EIRA concept: eira:ArchitectureBuildingBlock
Last modification: 2023-08-20
dct:identifier: http://data.europa.eu/dr8/egovera/MedicalDevicesSystemApplicationService
dct:title: Medical Devices System (MDS) Application Service
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eira:PURI | http://data.europa.eu/dr8/egovera/MedicalDevicesSystemApplicationService |
dct:modified | 2024-00-11 |
dct:identifier | http://data.europa.eu/dr8/egovera/MedicalDevicesSystemApplicationService |
dct:title | Medical Devices System (MDS) Application Service |
dct:type | egovera:MedicalDevicesSystemApplicationService |
skos:definition | The use or consumption of feature provided by a medical devices system (MDS). A MDS enables health professionals and health control agencies to manage the registries of medical devices which can be prescribed to patients. |
eira:definitionSource | Healthcare Information and Management Systems Society (HIMSS) |
eira:definitionSourceReference | https://www.himss.org/library/medical-devices-system-mds |
skos:example | Examples of the application of the Medical Devices System (MDS) include: 1) A manufacturer registering a new medical device in the system, providing all necessary documentation and data for regulatory approval. 2) A healthcare provider reporting an adverse event related to a medical device, which is then tracked and analyzed by the system. 3) A regulator using the system to monitor the post-market performance of a medical device, identifying any potential safety issues and taking appropriate action. 4) A patient accessing information about a medical device, including its safety record and any recalls or warnings. |
skos:note | The Medical Devices System (MDS) is a comprehensive digital service that encompasses a wide range of functions. It includes the registration of medical devices, tracking of adverse events, post-market surveillance, and risk management. The system is designed to facilitate the exchange of information between manufacturers, healthcare providers, regulators, and patients. It provides a centralized platform for the reporting, analysis, and dissemination of data related to medical devices. This includes data on device performance, adverse events, recalls, and patient outcomes. The MDS also supports the development and implementation of regulatory standards and guidelines for medical devices. |
eira:concept | eira:ArchitectureBuildingBlock |
eira:view | TVA-Health Patient Summary Enablers [Motivation] |
eira:view | Technical view - application |
eira:businessDomain | health |
eira:eifLayer | TechnicalApplication |
skos:broader | http://data.europa.eu/dr8/DigitalSolutionApplicationService |