EUDAMED: Add my device data
The EUDAMED device module will be live in September 2021. The EUDAMED database is complicated and requires a large amount of data from medical device companies. The biggest question all companies must ask themselves is what is the best option for me to add my device data.
The European Commissions EUDAMED allows for three options to add data:
1. Web-based forms. These are ideal if you have a very small amount of devices as they take a lot of time to complete.
2. XML Bulk upload. This allows users to manually upload XML files containing up to 300 entities. E.g. 300 UDI DI’s. This is pretty efficient, for 15,000 devices this is roughly 50 files. However, the XML creation is fraught with danger, one simple XML mistake and the entire file of 300 is refused. There are a large number of rules the data must pass before it is accepted so the XML must be perfect, which takes a lot of time to perfect
3. Machine to Machine (M2M) transfers. M2M transfers are the automated uploading of your XML files. The XML file files are the same as the bulk upload files with some additional XML. This is very impressive from an IT perspective however it is also the most costly option. The costs come from the need for an Access Point, €5000+ per year are quotes we have seen for managed services. One quick point on this, you do not have to own your access point you can use a third-party service offered by Eudamed.com
Using the XML uploads is by far the best option for getting your data into EUDAMED. You need to select or create a solution that must meet certain criteria otherwise, quite simply you will end up wasting a lot of time and money.
The criteria for selecting a system are simple, firstly the selected system must validate your collated medical device data before it is uploaded to EUDAMED. There is no point in uploading data to EUDAMED that will be refused because of errors, your data must pass validation first. Next, the system must convert the error-free device data into the exact XML format required by EUDAMED, again badly formatted XML will be refused by EUDAMED. The system must provide you with the messages received from EUDAMED, these messages include, delivered, consumed, success or refusal messages. You need to know if your data has been accepted or refused and for the refused messages you must also manage the data upload batches to avoid duplicate device uploads.
These criteria all sound fairly simple however there is one more vitally important condition that you must insist on, batch management. Each batch creates an XML file containing and managing up to 300 entities. Properly created and managed batches will ensure that you do not accidentally upload multiple versions of the same device. Don’t forget these versions will all be visible to the public and the public will not be informed that each version in EUDAMED is only a data version, they will see multiple versions and assume it is multiple device versions. So batch management is crucial in selecting or creating a system to manage your device data uploads.
Eudamed.com has two options to help you get your device data to EUDAMED.
1. Firstly, EudaMed SaaS, there are two ways to use this system. Firstly, we can offer you full data validation and a last-mile delivery option useful for companies who have built an internal system to collate all the required data. This system takes your data in JSON format, validates it and provides you with PDF files showing any errors for each entity. If the data is error-free, we create and deliver the XML then return the EUDAMED messages to you. Full batch management is in operation.
EudaMed SaaS can also accept the Eudamed.com spreadsheet templates populated by you and uploaded directly to EudaMed SaaS.
2. The second option is EudaMed+ which is installed on your internal servers and has full data and batch management. The system incorporates web-based forms just like EUDAMED for you to add your data, clone functions to reduce data entry, version management, bulk updates across selected records, full data validation against the EUDAMED rules, XML conversion, EUDAMED data submission, and EUDAMED message retrieval. Everything you need to manage your EUDAMED interactions.
These two software options work for single SRN and multiple SRN owning companies, for companies that manage manufacturer data and wish to expand their offers to allow their client to upload EUDAMED data via their system.
Regardless of how you get your data ready and delivered to EUDAMED, if you want to sell your medical devices within Europe you will eventually have to enter them into EUDAMED. The EudaMed.com speciality is to help you manage EUDAMED as easily and cost-effectively as possible.
You can book a free demo of our software here: EudaMed Software Demo.
We also provide exclusive Eudamed training, live online or on-demand videos, which covers everything associated with getting your data into EUDAMED. Eudamed.com training schedule.
For everything EUDAMED, EudaMed.com is here to help you.