EUDAMED Services

EUDAMED is a very complex application with hundreds of different data requirements and business rules. The European Commission(EC) has published many of the documents required for companies to proceed with both their change management and IT projects, the links are available here. Everything companies need to proceed has been published. Because of the complexity, the possibility of mistakes, and several weeks of research to understand the EUDAMED requirements, training is essential. EUDAMED training will save your organisation time and effort in needless research and analysis of the EC requirements.

We provide exclusive online EUDAMED training and when possible on- and off-site training in various managed locations for group training sessions. We provide a Technical course for IT personnel and a Non-Technical course for Management, Consultants, and RA / QA professionals to understand the complexities and dependencies of MDR EUDAMED including the related EC publications. Courses cover Actor Registration, UDI Device, Data Submission options including Bulk Upload and Machine to Machine Data Exchange. In addition to the UDI Device XSD’s, XML formats, application business rules, and how to prepare your data for upload to the EC Eudamed database.

We cover everything needed to prepare and submit your data to EUDAMED. At the end of the two half-days of training, you will be EUDAMED ready, see our schedule here.

Software as a Service is a complete service to get your data ready for you to upload to EUDAMED. This service consists of three building blocks:

1. MDR and IVDR spreadsheet template packages to help you collate the required EUDAMED data.
2. The Validator – Validates the data you entered in your spreadsheets against the EUDAMED rules.
3. The Converter – this converts your validated data into XML ready for you to upload to EUDAMED.

The Validator

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 in each PDF is managed by the user uploading the spreadsheet in the web app, they have the option to have up to 100 UDI DI’s 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(s) in 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 zip file containing all the PDF’s related to you 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 EUDAMED.

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 is error-free then you are ready to convert the data to the required EUDAMED XML structure which our Converter can do for you.

The Converter

The eudamed.com service ‘The Converter’ takes your spreadsheet template as per the Validator, 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 same 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 result in 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 and costly 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.com 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.com 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 this complete service can benefit you.

There are many ways eudamed.com can support your company when dealing with MDR-Eudamed. This is a very complex application and unless you are using it every day it can be time-consuming managing this system.

We can, if you wish, take care of your user management. Validating new users and removing users who have moved on.

Next, we will support and assist you with issues relating to the data preparation, XML, XSD data validation, validating against the EC’s business rules and the machine-to-machine data exchange, we provide last-mile delivery service using our access point. If you wish to set up your own access point we can assist with that, too.

User management 

We can also act as your user administrator for the MDR-Eudamed application. MDR-Eudamed is our daily business. We are experts in this application, along with its user and data management. We would be more than happy to look after any aspect of the MDR-Eudamed application that you need assistance with.

Data preparation and data exchange

The support package includes assisting you with your XML, the XSD validation and clarification as to why your uploads may fail. Problems with eDelivery or errors on the front end of the application? We can assist you with all of them.

MDR-Eudamed is our business. We are aware it is not your main business, yet this is an application you have to use. Let our expertise solve your MDR-Eudamed problems.

eudamed.com can help at every point of this process from training to support, data processing, validation, project management, to uploads. In addition, we offer a full MDR-Eudamed managed service, taking care of everything on your behalf.

We can provide you with as much assistance as you need, MDR-Eudamed is our business, let our EUDAMED experts solve your MDR-Eudamed problems. Contact us to see how our services can benefit you.

MDR Eudamed requires perfectly prepared XML data for upload to the EC.  The XSD’s from the EC are exceptionally complex and come with an exceptional amount of business rules. Understanding these will take your IT team a lot of costly time. Companies can save on IT resources valuable time by bringing us is to consult and not only on the EC requirements, but we can also assist with your overall strategy for preparing your systems to integrate with the EC requirements. We are available for expert MDR Eudamed consultancy and/or project management.

Part of the IT project you will need to consider are the data upload options, and the costs financially and in the ongoing IT resource requirements. Upload options include machine-to-machine with your own CEF eDelivery access point or, more cost-effectively, using our access point, maintained and supported by eudamed.com. Regardless of the option used for upload, the XML must be perfect otherwise your data will be rejected by the EC. Manufacturers and notified bodies will be required to prepare their XML data, not only for validation against the EC’s XSD but also to meet the EC’s complex and extensive business rules.

The size and complexity of these projects should not be underestimated. These will not be one-off data transfers – there will be multiple uploads over many years, including ongoing changes and maintenance required. The preparation of the data and the conversion to the correct formats, in order to meet and pass XSD and the business rule validations, takes substantial time and expertise, we can help reduce the burden for you. We are the only company in the world to have had hands-on experience with the development and implementation of MDR Eudamed.

Regardless of our involvement in your project, we urge you to start as soon as possible. These projects can take considerable time and depend on the expert assistance you have at your disposal, these projects can be extremely costly and complex.

We have many years of experience and the necessary expertise in this area to assist you with your project. We have extensive experience in preparing various systems for use with European Commission EUDAMED and other applications. The XSD and XML structures the EC will use for MDR Eudamed are very similar to ones used by many other EC applications. From concept, to design, to implementation, we can take care of this project for you, whether working in conjunction with your IT department, working as part of your team or as a fully independent team using the data you provide.

Our team can get your eDelivery access point working and integrated with your delivery systems, also get your REST or SOAP services designed, implemented and delivered using our MDR Eudamed knowledge, in addition to managing and preparing your XML data for upload to MDR Eudamed. Whatever your needs, we can help.

eudamed.com 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.

We can provide you with as much assistance as you need. MDR Eudamed is our business. Let our expertise solve your MDR Eudamed problems. Contact us to see how our services can benefit you.

The machine-to-machine exchange of data between MDR Eudamed and end-user systems is an incredibly useful feature. The EC will use CEF eDelivery access points as the transportation layer for machine-to-machine uploads and downloads.

The implementation of eDelivery is not to be underestimated – this uses a complex AS4-protocol-based transportation layer know as an access point. An access point is required by you and connects to an EC access point. The EC does provide a free access point software called ‘Domibus’ which in itself is not complex however the implementation, configuration, management and application integration with your systems, is most definitely complex.

We, as MDR Eudamed experts, can take care of this issue for you. There are two options for you. 1. We help you install, configure, maintain, manage, and integrate your own access point, with your application, on your own premises OR 2. you can use our access point to deliver your data.

1. We can assist you with the installation, configuration, PKI certificate configuration, set-up and testing of your access point, plus if required general management is available. In addition, we can also help you with the integration with your own systems so you can pull and push messages to and from the EC.

2. We are what is called a ‘last-mile delivery company’ or ‘3rd party provider’. You can upload your eudamed.com spreadsheet files to us, using straightforward REST services, or using our application GUI. After a successful upload to us, if you wish, we can also process/validate/upload the data for you, or simply upload it, on your behalf, to the EC’s Eudamed database system using our access point.

You can upload your prepared XML files to us. We will then forward them to the EC using our access point, without our validation processes being used.

Or if you wish we also provide full data processing and validation services to make sure there are no rejected uploads from the EC. We ensure the data in your XML file is validated against the EC’s XSDs and that it meets all the complex EC business rules.

eudamed.com can help at every point of this process, from training to support, data processing, validation of the XML, project management, to uploads. In addition, we offer a full MDR Eudamed managed service, taking care of everything on your behalf.

We can provide you with as much assistance as you need. MDR Eudamed is our business. Let our expertise solve your MDR Eudamed problems.

Contact us to see how our services can benefit you.

The CEF eDelivery access points are complex, Domibus is the EC’s free access point software. Integrating your systems with Domibus, required to allow the Access Point to transport your data to MDR Eudamed, requires an application plugin to be created. This additional piece of software can take substantial time to create, in particular, if your IT team are not familiar with Domibus and have not created one previously. Because of our extensive experience with Domibus we can create this required plugin in a fraction of the time it would take a team that is not familiar with the Access Point.

Let us help you save time and investment by assisting you with your MDR Eudamed access point integration.

We can provide you with as much assistance as you need. EUDAMED is our business. Let our expertise solve your MDR-Eudamed problems. Contact us to see how our services can benefit you.