MDR-Eudamed data requirements, business and XML rules, are complex and extensive. Let Eudamed.eu ensure that your data meets all of these rules prior to you or Eudamed.eu uploading your data to the European Commission’s MDR-Eudamed.
Uploading incorrect or invalid data will result in your upload being refused by MDR-Eudamed. The EC has not stated what auditing of uploads will take place. They have not outlined the consequences for multiple upload failures when attempting to upload invalid data.
Our web application service ‘The validator’ accepts the uploaded Eudamed.eu 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.
For all the options, if you want training, support, your 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.