In September 2019, we witnessed PLM software giant, PTC Windchill, quietly exit the UDI compliance market. As we ended 2019, several little birds have shared that GHX is slated to phase out support for their UDI Data Submission Service and will not be providing a EUDAMED solution market overall. This marks a shift in their solution strategy to focus on helping healthcare providers with tools to consume trusted master data.
If you’re a medical device manufacturer or supplier submitting data to the FDA’s GUDID system via GHX, then this development could seriously impact your ability to comply with the FDA’s UDI regulation. It appears that GHX will discontinue support of their existing GUDID solution, which is based on the PTC product, and will not be developing a solution for Europe’s EUDAMED. So, if you are a GHX customer, how will your company submit UDI data to the FDA’s GUDID moving forward and how will you meet the upcoming EUDAMED compliance needs… and beyond?
Building a proprietary, in-house system may be a quick temporary fix, but this will become expensive to scale as your long-term regulatory compliance solution when China, Saudi Arabia, South Korea, and Australia introduce their own UDI programs. How will your IT team support these new market needs?
Perhaps it’s time to consider this alternative – a scalable and proven solution for direct M2M data exchange to the GUDID – using Innovit’s UDI Connector as your FDA-approved “Third‑Party Submission” system. It reduces your IT ownership costs and simplifies regulatory compliance processes, especially end-user support, training, documentation and system validation.
Innovit is also scheduled to release its “EUDAMED Connector”, an M2M data exchange solution for:
- Structured master data submissions (BUDI and DI data), and
- Unstructured regulatory forms submissions (including FSCA, FSN, MIR, PMCF, PSUR, Trend reports, Clinical Investigations)
Our solution will support both GUDID and EUDAMED data management and submissions – to deliver a consistent, unified user experience for your Regulatory Affairs, Quality Assurance and Master Data professionals.
The EUDAMED Connector will capture your SRNs (Single Registration Numbers) from the Actor Registration process, Conformity Certificate identifiers from Notified Bodies, and all the device data as inputs to the manufacturer’s device registration and UDI submissions. It is planned to support the following modules for EUDAMED data submissions:
- Device registration and UDI submission
- Vigilance reporting
- Post Market Surveillance reporting
- Clinical investigations and performance studies
We’ve also designed this system to be extensible, and scalable to support the emerging UDI requirements of Regulators in other jurisdictions.
If you’re interested to learn more about how we can help, talk today to our Regulatory advisors!