EU MDR/IVDR creates some unique challenges over and above the challenges presented by US FDA UDI. For Innovatum, compliance with EU MDR/IVDR is merely an extension of our already proven US FDA UDI solutions. We combine our technology with our on-going experience gained from helping our notable customer base to deliver complete solutions.
EU MDR/IVDR compliance considerations involve but are not limited to:
Labeling – includes patient implant cards, destination labeling, flexibility for home care product labeling requirements, satisfying combination product requirements, ability to support mass update of labeling data such as notified bodies, and delivering eIFU capabilities.
Master Data Management (MDM) – includes a flexible capacity to add columns to manage new information such as regionally specific classifications and characteristics. Combining enterprise data with a browser-based interface to allow different departments to collaborate with in-country review and approval capabilities.
Regulatory Data Submissions – includes an extensible ability to submit data to EUDAMED, US FDA UDI (GUDID) and other regulatory bodies as their requirements develop. An unparalleled capacity to reuse single source of truth data for multiple purposes.
Handling Multiple Concurrent Endeavors – multiple regulatory data management and submission requirements along with labeling can be efficiently handled with one proven system from Innovatum.
Efficient compliance with EU MDR/IVDR demands masterful control of master data. It also requires a proven, fully featured, and capable labeling system. The right systems and expert guidance based upon extensive experience and industry leadership can make all the difference.