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Eudamed Data Exchange and Access Points
The machine-to-machine exchange of data between MDR Eudamed and end user systems is an incredibly useful feature. The EC will use CEF eDelivery access points as the transportation layer for machine-to-machine uploads and downloads.
The implementation of eDelivery is not to be underestimated – this uses a complex AS4-protocol-based transportation layer know as an access point. An access point is required by you and connects to an EC access point. The EC does provide a free access point software called ‘Domibus’ which in itself is not complex however the implementation, configuration, management and application integration with your systems, is most definitely complex.
We, as MDR Eudamed experts, can take care of this issue for you. There are two options for you. 1. We help you install, configure, maintain, manage, and integrate your own access point, with your application, on your own premises OR 2. you can use our access point to deliver your data.
1. We can assist you with the installation, configuration, PKI certificate configuration, set-up and testing of your access point, plus if required general management is available. In addition, we can also help you with the integration with your own systems so you can pull and push messages to and from the EC.
2. We are what is called a ‘last-mile delivery company’ or ‘3rd party provider’. You can upload your data files (XML, Excel etc.) to us, using straightforward REST services, or using our application GUI. After a successful upload to us, if you wish, we can also process/validate/upload the data for you, or simply upload it, on your behalf, to the EC’s Eudamed database system using our access point.
You can upload your prepared XML files to us. We will then forward them to the EC using our access point, without our validation processes being used.
Or if you wish we also provide full data processing and validation services to make sure there are no rejected uploads from the EC. We ensure the data in your XML file is validated against the EC’s XSDs and that it meets all the complex EC business rules.
We can help at every point of this process, from training to support, data processing (JSON, CSV, Excel to XML), validation of the XML, project management, to uploads. In addition, we offer a full EUDAMED managed service, taking care of everything on your behalf.
We can provide you with as much assistance as you need. MDR Eudamed is our business. Let our expertise solve your MDR Eudamed problems.
Contact us to see how our services can benefit you.