Eudamed.eu can help you prepare your medical device data for upload to EUDAMED. Data preparation is not simply about converting it to XML, there is also the validation against the many rules, XSD and the European Commissions business rules. Failure to validate correctly or to meet the defined business rules means your data uploads will be rejected by EUDAMED. We have various services to help you. Firstly you must populate our spreadsheet templates, our services then import these templates, validate the data and convert it to the required XML structure. The MDR template package and the IVDR template package have many built-in EUDAMED rules to help you. Our Validator and Converter services will do the rest, leaving you ready to upload whenever you are ready.
Our web application service ‘The validator’ accepts the uploaded Eudamed spreadsheet(s) you have populated. Our system then prepares PDF files of the spreadsheet data, split into Basic UDI and UDI DI files. The number of UDI DI’s per PDF is managed by the user uploading the spreadsheet in the web app, they have the option to have up to 100 devices in each PDF.
Tip: For easy of validation and to make life easier on your data reviewers, the spreadsheets should be split into product family groups. You can also track the various spreadsheet updates within your own document management system so you always have history and backups.
After you upload the spreadsheet file to our web application you receive a message stating upload was successful, then we start processing in the background when we are complete you will receive an email which contains a link to a zipped file containing all the PDF’s related to the spreadsheet upload. The Basic UDI’s have been separated from the UDI DI’s to ensure faster processing and easier reviewing. These PDF’s can now be reviewed by your responsible persons to ensure that the spreadsheet data is correctly prepared for a EUDAMED upload.
To make the validation easier, all mandatory fields are highlighted if not populated or if errors are detected. Missing or not populated sections are highlighted to ensure the reviewer has all the facts. The system validates against the European Commission’s business rules and you are also presented with a list of failed rules if any such failures exist. If your data has no errors then you are ready to convert the data to the required XML structure.
The eudamed.eu service ‘The Converter’ takes your spreadsheet, re-validates the data for safety and if it is error-free your data is converted into the XML files required by the European Commission. If errors are discovered during the process the user is alerted in an email, which contains a link to the same zip file containing the PDF files the Validator creates so they can be reviewed. If no errors are discovered then the data is converted to XML and you are emailed, this email contains the PDF files for your records and the XML files, you are now ready to submit your data to EUDAMED using the European Commissions EUDAMED ‘Bulk upload’ option. This bulk upload is suitable for small and large amounts of UDI DI’s. For example, 15,000 devices are only 50 XML files to upload as the EC allows 300 entities per file. The Converter is available via our web application.
Using the ‘Bulk Upload’ option is far cheaper than the very resource-heavy Machine to Machine option which can cost many multiples of the ‘Bulk Upload’ option.
For all the options, if you want the data prepared, validated and ready for EUDAMED, then we can help you. Contact us with any questions, we will be more than happy to assist you.
Eudamed.eu can help at every point of this process from EUDAMED templates, training, support, data processing, validation of your spreadsheet data, conversion to XML with the messages ready for ‘Bulk Upload’, project management, to ‘machine to machine’ uploads if required.
As much assistance as you need – Eudamed.eu can provide it. Eudamed is our business, we are available for “everything EUDAMED”. Let our expertise solve your EUDAMED problems.
Contact us to see how our services can benefit you.