EU MDR IVDR

Innovatum Has EU MDR IVDR Solutions Available Today

EU MDR regulations create some unique challenges over and above the challenges that have been presented by US FDA UDI. One of the biggest challenges is that we have deadlines to hit without having a complete set of requirements. For Innovatum, working on compliance with EU MDR IVDR is merely an extension of using our already proven US FDA UDI solutions. The systems that we deliver today are easily extensible to handle any compliance requirements that arise. The key to doing this is flexibility in design.

It is all about the flexibility of working with data. This includes the ability to find everything you are looking for quickly and change your direction in an efficient and 21 CFR and Annex 11 compliant way for EU MDR implementation. Create new fields to store data without needing to involve IT or needing to revalidate your software with each system change. This is because the ROBAR system gets validated for its ability to allow authorized users to make changes to the system. This includes aggregating data by creating and saving search criteria and then giving controlled access to divisions, subsidiaries and partners in a self-service portal.

Allowing you to focus upon the complexities that are difficult to automate
instead of unnecessarily living with complexity that can be easily automated.

For example, store multiple levels (aggregations or groupings) of BUDI data, and then quickly find filter, and enact mass changes against that data as specific BUDI requirements become more defined. Capabilities for managing Implant cards, their electronic counterparts and their printing already exists today.

EU MDR software compliance considerations involve but are not limited to:

Labeling – includes medical device implant cards, destination labeling, flexibility for home care product labeling requirements, satisfying combination product requirements, an ability to support frequent changes of 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 (once specifications are released) as well as US FDA UDI (GUDID) and other regulatory bodies as their requirements develop. An unparalleled capacity to reuse singular source of truth data for multiple purposes.

Handling Multiple Concurrent Endeavors – multiple regulatory data management and submissions 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.