If you’re a medical device manufacturer or supplier submitting data to the FDA’s GUDID system, then your life may be getting a bit more complicated if you’re also using PTC’s UDI solution to comply with this FDA regulation. Recent announcements suggest that PTC is exiting the UDI compliance market altogether. It will discontinue development of their existing solution for GUDID and will not be developing a solution for Europe’s EUDAMED. So, if you are a PTC customer, how will your organization submit UDI data to GUDID moving forward and how will you meet the upcoming EUDAMED compliance dates in May 2020?
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, South Korea, Australia and Saudi Arabia introduce their UDI programs. For example, consider China’s recent announcement of their NMPA’s pilot for medical device regulation (starting October 1st, 2019). How will your IT team plan to support this new market need?
Instead, consider this alternative – a scalable and proven solution for direct M2M connection 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 end‑to‑end 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 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 for other national regulators.
If you’re interested to learn even more about how we can help, let’s talk today!