EUDAMED deadlines remain unchanged – the go-live date is still March 26, 2020 with the Date of Application for device registration/submission standing at May 26, 2020. Yet, we’re nearing the end of 2019 with most med device companies still struggling to fully understand the requirements. Many have opted for a wait-and-see approach – hoping for the EU Commission (COM) to release comprehensive technical specifications and guidance – before committing to a solid tactical plan for solution development. Unfortunately, as of our work-group on October 3rd, the COM confirmed that no further technical specifications will be published by them. In fact, the COM has quietly made it known to industry players, not to anticipate final MDR data requirements, data validation rules or updates to the MDR XSD’s.
Okay, now that you’ve tried the waiting game, you’ve probably realized that you simply cannot afford to wait any longer. You must start preparing your data for submission to EUDAMED. You must plan for how you are going to interact with EUDAMED, as they will require all the BUDI and UDI information, certificates, MIR forms and much, much more. This is a major project and one that could affect your European revenue if you get it wrong.
Let’s talk about how Innovit can help. Working with our team is far more time-efficient than attempting an in-house development approach (especially given the lack of technical specs). We have the knowledge and experience and we are the ONLY solution provider who has successfully tested device registration with the EU Commission to date.
What do we mean by testing? Here’s some background:
Earlier in July 2019, the COM released a EUDAMED ‘playground’ for both GUI-based access and M2M data exchange for Actor and Device/UDI submission modules. Innovit was part of a select group of solution companies given the task of testing this process and reporting back to the EUDAMED DTX Workgroup in early October. It was – and is – a privileged position as it gives early access to understand the ‘how’ of M2M data submission and in return, provide feedback and findings to the European Commission.
Innovit and six other solution providers conducted testing throughout September. At the conclusion of the initial testing period, we were the only solution provider able to complete all the test cases for Device Registration. Those test results were published by the EU Commission. Based on these initial findings, MedTech Europe requested Innovit to provide a summary of tests and recommendations to the COM.
Today, we’re leading the charge for M2M testing working alongside other MedTech Europe members. We offer a unique platform to deliver a M2M EUDAMED solutions through hands-on experience in the early rounds of testing.
Projections for 2020 (EUDAMED):
Looking ahead to EU MDR and the EUDAMED requirements, we are scheduled to release the Innovit EUDAMED Connector, an end‑to‑end solution for both:
- Structured master data submissions (BUDI and DI data) and
- Unstructured regulatory data submissions (FSCA, FSN, MIR, PMCF, PSUR, Trend Reports, Clinical Investigations)
Our solution will deliver a seamless user experience for the Regulatory Affairs, Quality Assurance and Master Data professionals. The EUDAMED Connector will capture the SRNs (Single Registration Numbers) from the Actor Registration process, Conformity Certificate identifiers from Notified Bodies, and the device data as inputs to the manufacturer’s device registration and UDI submission systems. We plan to support the following three modules for EUDAMED data submissions:
- Device registration and UDI submission
- Vigilance reporting
- Clinical investigations and performance studies
Priority will be guided by the EU Commission roll-out plan – with Device Registration being the first for Innovit’s EUDAMED Connector.