The European Commission (EC) has finally published the UDI Device data requirements. The long awaited data structures are now available. Companies can and should start preparing their MDR Eudamed data submissions. Where to start?
Companies should start by reviewing the information released from the EC, and for companies that need help understanding and assessing these documents. Please do not forget eudamed.eu provides training, support, and consultancy to help with companies understanding of not only the published documents also the EC requirements.
- Data Dictionary
- MDR attributes
- IVDR attributes
- Data exchange services and entity models introductions
- M2M Data Exchange Services Definition
- Data exchange guidelines
- XSD – UDI Device
- UML Diagrams
- XML Samples
You have the information to start making some decisions as to how you will prepare and submit the required data, the business rules will come in a few weeks but you can start now.
If you have less than approximately 20 devices then the web interface and manual data entry may work for you, be careful as data entry errors can have unintended consequences we would recommend bulk upload in almost all cases. For 20 to roughly 15000 devices, manual XML bulk uploads can be competed by preparing your XML and using an upload form within the Eudamed application; however, you will still need to prepare validated XML data, we can help with this if the data is provided to us using our Excel templates..
First, you need to collate your data, our templates can help you do this. They have been prepared using all the published information from the commission including many of the rules you will need to pass. These templates are designed to adhere to the EUDAMED XSD formats which means creating the XML for upload is a lot easier and a more cost-effective task if you use our MDR and IVDR templates.
For those with over 15,000+ devices and/or even those who want to automate the process with far fewer than 15000 devices then you can use the machine-to-machine interface, this is the most costly and complicated options from the EC. This is the first decision to make, how to submit the data.
If you decide on XML uploads, following an initial review of the XSD’s, data dictionary and the business rules, you should be able to assess the complexity and scale of the project.
One question that must be considered, do you complete the full IT project in-house or outsource?
A skills gap assessment needs to be undertaken, specific skills are required.
- XSD / XML experts are required, not just someone with a vague idea but a real expert.
- A technical analyst to break down the business rules into code-able information.
- Someone to retrieve the correct data from the in-house system.
- Programmers to write software to validate the data against the business rules.
For machine-to-machine data deliveries, additional resources are needed:
- A networking person to learn about, set up, and maintain an eDelivery access-point.
- Finally, a system integrator to take connect the access point to the organizations software, for validating and producing the XML.
If those skills are in-house, that is great; otherwise, a hiring process must be undertaken quickly. There is a shortage of qualified experiences IT resources, and it takes a lot of time to complete all the required HR processes even for freelancer contractors.
Next, the technical analyst needs to start ASAP, taking the EC information and turning it into something useful for the programmers to deal with. A lot of time will be invested in gaining a good understanding of the data structures, rules and requirements, both by the technical analyst and by the programmers.
Saving solution: A training course on preparing your UDI Device data for EC submission. Eudamed.eu is running courses on how to prepare, one-day workshops onsite or in external locations to save you additional efforts. There are also on-going support services available.
Once your IT team has all the information, the IT project planned and resourced, and work packages prepared, it is time to start programming. Taking your data, validating it against the EC rules, and converting it to XML for the final validations against the XSD rules. Finally, you have validated XML packaged and ready to send to MDR Eudamed.
If the decision made was to use machine-to-machine interfaces, your programmers and integrators have some additional work to do. After submitting a request via a form in Eudamed for an eDelivery access point. DIGIT (EC IT Services) will assist the requesting organisations with instructions on configuring the access point to connect to the EC.
Note: The EC will NOT assist with your software system nor with the required system integrations between the access point and your software system. Your team will take care of this work, including how to process the messages returned machine-to-machine by MDR Eudamed. There will be a lot of notification messages, from delivery accepted, to processing started and finally successful or unsuccessful messages. These need to be processed.
Saving solution: You can use the access point from Eudamed.eu — no setup and maintenance required to form your team, and still machine-to-machine. Alternatively, Eudamed.eu can set-up, manage, and maintain an access point in your network for you.
Once the business rules are implemented you are ready to upload your validated data.
Note: A conservative estimate of costs for such a project, excluding the ongoing maintenance and updates, the required project will cost the average company approximately €150, 000
Outsource all or part of the project
If you decide not to take the burden in house, Eudamed.eu provides many services to assist.
Our Software as a Service costs a fraction of an in-house project. We have already completed the hard work for you, all you do is submit your data to us and we take care of the rest.
Training, you can save yourself a lot of time and effort by attending one of our training courses. We explain the XSD structures in detail, including how to encapsulate your XML data so the EC accepts it. Available in your premises or in various external locations.
Support, if you have problems with the XML, understanding the messages from the EC regarding your data, who will help you? Who will explain the upload failure notices you receive? Eudamed.eu is providing support services where you can call or email your issues and our expert team will help you with your MDR Eudamed data queries.
Consultancy, our team is the only team in the world to have had any hands-on experience with MDR Eudamed. We actually helped architect, manage, and implement the system. Who better to consult and help you with your Eudamed needs?
Access Points, an eDelivery access point is required for the machine-to-machine interface with MDR Eudamed. There is a complexity involved in setting up, maintenance and managing access points, in addition to the integrations with your in-house systems. We can help you with a managed service; we will set up and manage the access point for you. Alternatively, you can save yourself a lot of time and effort by using our access point. On the other hand, if you want your own on-site access point but do not want to set it up, manage it and maintain it then we can help, our team are experts in this area.
Whatever your MDR Eudamed needs we can help. We wish you the best of luck with this project, but please start early as there are up to 80,000+ companies going to be chasing the same resources.
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