The European Commission adopted Medical Device Regulations in 2017. There are two regulations, Medical Devices Regulation (MDR 2017/745) and the In Vitro Diagnostic Medical Devices Regulation (IVDR 2017/746). EUDAMED is at the core of both regulations. EUDAMED is the IT system used to monitor the safety and performance of both MDR and IVDR regulated medical devices. Economic operators consisting of Manufacturers, Importers, European Authorised Representatives, and System or Procedure Pack Producers are obliged to register their companies.
EUDAMED is live since December 2020, albeit in a limited capacity with only one of the six main modules available. The Actor module is used by Economic operators to register and receive their Single Registration Number (SRN). The SRN is required for the ‘Declaration of Conformity’ and certificates. It should also be communicated in ‘Field Safety Notices’. EUDAMED will allow public searches of devices, actors and the other modules, the UDI on the label will allow the public to trace back to the SRN of the manufacturer.
The Actors Module
The Actors module is not only for you to register for your SRN this is also where you manage company user accesses, users rights and roles, company details, changes in Person(s) Responsible for Regulatory Compliance (PRRC), and the communication addresses for the various EUDAMED modules. This is also where the overall access to Machine to Machine data access is managed by your local actor administrator (LAA). This module is central to your access and management of all other modules.
The Device Module
The EUDAMED Device module is coming in May 2021, this module is for registered companies to register each of their devices. Companies must now decide on their strategy for getting their data into EUDAMED as it requires a lot of device data. For those who are used to uploading their data to the FDA, it is worth noting that the EUDAMED’s data requirements should not be underestimated, they are far more complex.
We estimated that a basic in-house created IT system for companies to prepare their data for upload to EUDAMED would cost more than €150,000. Why should companies invest so much in a new system? Companies have no choice if they want to sell products in the European Union submitting device data to EUDAMED is mandatory, however, creating their own IT system is not mandatory.
Help is at hand, there is no need for you to re-invent the wheel, we have completed the work for you. Eudamed.com has two solutions costing a mere fraction of the price if your IT team were to build a solution for you. Our solutions can assist you in collating, preparing, and validating your data leaving it ready for EUDAMED uploads. For a free demonstration please do contact us.
Data Entry Options
EUDAMED provides three options for you to enter your device data into the system, manual data entry and two options using XML files containing your Basic UDI’s and UDI DI’s. These XML files can be uploaded manually to EUDAMED or using a far more expensive and complex automated solution using an automated Machine to Machine option, which on average costs €5000+ more per year than the manual XML upload option.
Converting your medical device data to validated XML for either manual or machine to machine upload is a complex operation. For your company, the only difference between these two options is first cost and secondly a small manual file upload task. Eudamed.com has software for both options, regardless of your UDI DI count. You decide your needs, we can help guide you but ultimately it is your choice which option you decide to use. To help you decide we are offering online demonstrations of our EudaMed+ and EudaMed SaaS options, which will allow you to decide the best approach for your company.
Regardless of how you get your data into EUDAMED, and the complexity of the medical device regulation data requirements, you must decide on an approach, you must start preparing as EUDAMED will start accepting your device data in May 2021.