Tackling the Transition of GHX from UDI & EUDAMED Compliance — at the Same Time
GHX, a GDSN data pool and EDI solution provider, will phase out support for their GUDID Submission Service by December 2021, and do not have plans to provide a EUDAMED compliance solution. If you’re a medical device labeler submitting device data to the GUDID via GHX and also have the requirement to submit data to EUDAMED by Q4 of 2022, then this development could seriously impact your UDI compliance initiatives.
As a workaround, some companies are building proprietary, in-house systems, while others are outsourcing the process to a data submission service provider using Excel spreadsheets. This may be a quick temporary fix, but it’s not a scalable approach in the face of the unfolding global UDI requirements in countries like China, South Korea, Singapore, United Kingdom, Saudi Arabia, Australia and Brazil.
We have an alternative. Our recommendation is to simplify your global UDI submission processes, and tackle the challenges of replacing your GUDID solution while meeting the EUDAMED compliance deadline using Innovit’s Global Data Syndication Hub (GDSH). This system supports both GUDID and EUDAMED data management, data validation and submission requirements and provides you with a single solution that scales to other target markets at minimal incremental cost.
Minimize your IT ownership costs by simplifying your regulatory compliance landscape while reducing cost of change management – end-user support, staff training, process documentation and system validation.
Included in the Global Data Syndication Hub (GDSH) is Innovit’s UDI submission connectors for EUDAMED and GUDID that provide you with the most cost-effective solution to manage, validate and submit regulatory data to the FDA and EU Commission.
Our EUDAMED Connector supports the following modules for M2M (machine-to-machine) data submissions:
- UDI/Device Registration – Manage, validate and submit your Basic UDI-DIs, UDI-DIs, Legacy Devices, Product Designers, Market Information and Container Packs
- Vigilance – Manage, validate and submit your regulatory documents including MIRs, FSCAs, FSNs, PSRs, PSURs and Trend Reports
Get started today for free with Innovit’s EUDAMED.cloud freemium plans, and sign-up at our EUDAMED Reference Center – your one-stop website for UDI knowledge and everything you need to know about complying with EUDAMED!
Learn more: About EUDAMED.cloud!