Medical Device Regulation (MDR) are a set of recent European regulations aimed to enhance patient safety and modernize public health. Published in May 2017 by the European Commission (EU COM), they are an overhaul and expansion of the MDD (Medical Device Directives) first established in 1992.
Key elements of the new MDR include the expansion of the definition of medical devices; enhanced vigilance, market surveillance and traceability measures; and a centralized EU database for the storage of information on medical devices (EUDAMED).
EUDAMED is a momentous master data undertaking requiring the submission of regulatory & clinical information for every individual device sold in the EU economic zone including both structured master data and unstructured clinical documents. Medical device manufacturers doing business within the EU must comply with these requirements for Unique Device Identification (UDI) and device registration, necessitating that 180+ product data attributes and a dozen or so reports/forms be submitted to EUDAMED before its go-live date of May 2022.
In order to ensure a smooth and effective implementation, the EU COM is providing a “EUDAMED playground” available for both manual web-based user access and an automated M2M (machine‑to‑machine) Data Exchange for Actor Registration, Notified Bodies and Device Registration modules. Three solution providers – including Innovit – were invited to participate in this testing program and were approved to have Access Points setup for M2M data exchange with EUDAMED playground.
What exactly does the testing entail and why is it important?
The testing “playgrounds” were made available in different rounds and for specific time periods with test cases for each version. The process required each solution provider to set up their own M2M infrastructure and then submit data for specific test cases across MDR and IVDR (i.e. AS4 connections, access points, response messages) to cover both positive and negative scenarios for each test.
It’s important to mention that Innovit was the only solution provider that was able to complete all test cases for UDI/Device Registration prior to the first EUDAMED DTX Workgroup meeting and was asked by MedTech Europe to summarize Innovit’s findings for the European Commission.
Early access and testing of M2M data exchange in the EU COM’s playground was – and still is – hugely critical to the success of EUDAMED. This collaborative testing process gives us the opportunity to provide technical feedback to DG Sante, the EU Commission’s development team, to refine its system design as well as uncover problems or potential issues. Innovit’s development team then can make modifications and adjustments to our software solution as needed.
(Note that the next round of testing for Device Registration begins in late February 2021 and then twice yearly thereafter for DG Sante to incorporate any requested changes.)
How was Innovit able to be so successful with those initial rounds of testing?
We’re extremely fortunate to have a very talented Software Engineering team who are experts in Domibus (the opensource eDelivery AS4 conformant messaging Access Point implementation provided by the European Commission). We’ve also collaborated with MedTech Europe and had access to documentation and other insights. Therefore, we were able to set up Access Points and connections when others were not. Our team was able to complete the testing for both MDR and IVDR test scenarios during the second round of testing, when other solution providers were struggling to complete just the MDR tests.
Most companies struggled during testing and most were unsuccessful. Why was this the case?
First, we had access to the EUDAMED Device Registration playground. But true credit rests with the experience and commitment of our Software Engineering team, who had done similar M2M testing with the FDA for GUDID and GDSN data pools. The team knew what to expect. Our EUDAMED engineers were laser focused. Expertise, experience and focus made all the difference.
What are the key lessons learned?
From the technology perspective, we clearly found gaps in functionality within the database and made that known to the EU COM. They in turn were able to clarify which of those gaps would be addressed in subsequent releases. Knowing that our findings had an impact on the process was very gratifying because this was not the case with other solution providers.
As medical device manufacturers look ahead to 2022, what are Innovit’s main recommendations?
Our number one piece of advice is to start early. Submitting data to EUDAMED is a highly complex process and there are still many unknowns. Advice number two is to get your product data ready. MDR requirements are substantially different from those of the FDA. EUDAMED is far more extensive – covering both pre-market registration and post-market surveillance activities. Much more data is required, and the data validation process is different.
Once you’ve collected your product data, get started with M2M testing. (Remember, if you have large volumes of data you can’t do it manually. You will need to do so machine-to-machine.) Testing early is a wise move because you’ll also need to validate your data by the new rules and this process can get complicated. Further, you will need to validate your EUDAMED compliance system under GAMP 5 standards, which will also require a significant investment in time, effort, documentation and audit.
Next, we recommend that you iron out the messaging communications and data quality issues so that everything is ready by June 2021. Even though the submission deadline is not until May 2022, different modules are being released at different times by the EU COM. So, as the modules are released, your testing process becomes an ongoing exercise until at least the end of 2022.
What are Innovit customers doing to meet EUDAMED deadlines?
They are starting early! For example, customers such B. Braun Medical and Bio-Rad are initiating their EUDAMED projects now to enable comprehensive collection of the required master and regulator data, starting with Basis-UDI data. Their priority is collecting and cleansing product master data – M2M testing will come later.
Why work with Innovit?
Innovit continues to lead the charge for M2M testing working alongside other MedTech Europe members and has a unique platform to deliver an automated data submission solution for EUDAMED through our hands-on experience in the early rounds of testing. Innovit has the broadest coverage of testing for both MDR and IVDR testing. We are the only solution provider with both a direct connector for the FDA’s GUDID and a GDSN-based solution for UDI submissions. We are also the only solution provider for EUDAMED that is offering both structured master data submissions and unstructured data submissions (Vigilance and post-market surveillance forms and reports) – providing a ‘complete’ EUDAMED compliance solution for medical device data submissions.