Excellent news the EUDAMED Device and Certificate modules are live. It has been a long road but they are now live.
The European Commission(EC) has deployed the EUDAMED Device and Certificate modules and delivered a large amount of documentation for you to consume.
This huge amount of information is now available on EUDAMED for your to research and understand. You need to understand the EUDAMED requirements and this takes a lot of time. All the information is available in the Data Dictionary, XSD’s and XML examples, the DTX Services definition, the enumerations, and most importantly the business rules. There are several weeks of research in these documents before you even start thinking about creating a system to take your current data, validate it so it passes the business rules, and then prepare the XML in the correct format to pass the XSD rules, in addition, to managing the limits of how many UDI DI’s you can include in each XML file. There is a lot of research here so please do not underestimate the amount of time this will take.
If you do not have the time to research all these EUDAMED documents then why not let us help you. Following many requests, we have added new dates to our exclusive Eudamed training schedule.
EUDAMED is very complicated, but in this new release, there are some added complications related to the EUDAMED versioning of the Basic UDI’s, UDI DI’s, Market information, and Packaging. Originally the plan was to create a new version each time you upload an XML file, now before you create a new version you must specify in your XML the last upload version you uploaded for each entity. This may not seem like a big deal but it requires some really careful batch management and data retention for both the Playground and for Production because you may have different versions for your DIs in each environment.
We in Eudamed.com have been preparing for a long time for these EUDAMED modules to go live. Our software options EudaMed+ and EudaMed SaaS have both been designed to simplify the data management for you, not only manage the versioning complications but also to validate your data before it goes near EUDAMED. An infographic to show the software options and how they work.
Some tips for you, if you plan on entering data via the web application then you must have at least two users. One of which must have the rights for the Device module and remember only a “confirmer” can confirm the submission of the data.
If you wish to use the manual bulk upload option to upload your XML you must have the “confirmer” device module rights for EUDAMED, no other role can upload the files.
The XSD’s, XML samples, and data exchange information are at the bottom of this page here The business rules are available inside EUDAMED, click on the Help menu, then Documentation and these documents are available at the bottom of the page.
Special Offer to celebrate:
We have two special offers for our EudaMed SaaS subscriptions. For companies with up to 50 UDI DI’s or up to 150 UDI DI’s, some very special rates will apply. These offers include our spreadsheet templates to help you collate your data, our SaaS data validation service, and our service to convert your validated data to EUDAMED ready XML, perfect for EUDAMED upload. Please contact /" target="_blank" rel="noreferrer noopener"> for more information.
Our software options (EudaMed+ and EudaMed SaaS) can be used by companies with the lowest UDI DI counts to the huge companies with 100,000+ UIDI DI’s. We can accept your data in automated JSON files and deliver it directly and seamlessly to EUDAMED or you can enter the data directly into our application forms or indeed you can use our spreadsheet templates to deliver your data to us. We can work with you to deliver your data to EUDAMED in a way suitable for you.
EudaMed.com is here to help you with training, support, consultancy, and software, to help you get your data to EUDAMED.
Please do contact us, let the EUDAMED experts help you assess and address your needs.