As a medical device provider one of the biggest changes on the horizon will be the new EU requirements for product information, as well as the FDA’s GUDID compliance deadline for Class I medical devices.  

Even the most experienced companies uncover critical gaps in their own internal systems and master data.

Under current timelines, a fully functional EUDAMED system is expected to be ready for production use by mid-2023, when this system is published in the Official Journal of the European Union.

With so much happening in our world today, it’s hard to know where to find all the information needed to successfully prepare for EUDAMED compliance.

Introducing the EUDAMED Reference Center!

We’re thrilled to announce Innovit’s EUDAMED Reference Center – Your one-stop knowledge center comprising all of the documentation and training videos necessary to successfully prepare for and comply with EUDAMED.  Here you can find:

  • EUDAMED Overview
  • The EUDAMED Journey
  • EU Commission Published Documents
  • EU Commission Technical Documentation
  • MedTech Europe Published Documents.

At Innovit, we have you covered, with all the information and tools you require to meet evolving Medical Device Regulations (MDR) and EUDAMED data submission compliance.

So bookmark this page as your launch pad to find everything you ‘need to know’ about EUDAMED and your quest for compliance.

And coming very soon is our GUDID Reference Center!  Like our comprehensive EUDAMED Reference Center, but tailored for FDA’s GUDID data submission requirements.

We encourage you to visit Innovit’s website often as we continue this forward momentum with more exciting product launches in Q1 of 2022!