Healthcare Insights: Medical Device Regulation Updates – What You Need to Know

Keeping up with the evolving medical device regulation and compliance landscape can be challenging, particularly when technical specifications from the EU Commission are repeatedly delayed.  As a global software solution vendor for Life Sciences and Healthcare companies and members of MedTech Europe, we are well positioned to keep our customers and partners as up-to-date and informed as possible.

Let’s start by saying that after months of mystery, postponements and delays, Eudamed has finally released a bit of information.  Here’s the latest:

Eudamed

User Interface testing of Eudamed kicked off on July 15, 2019.  As part of MedTech Europe’s Eudamed IT Experts Group, Innovit will conduct testing until the end of August 2019. We’ll test the manual data entry to the Actor/User/Device registration webforms and provide input and feedback as requested.

Data Dictionary

The Eudamed data dictionary was also released on July 15.  We’ve been asked to provide comments to the Updated UDI & Device Data Dictionary + UDI/BUDI hierarchy document this month.

More

And finally, the Eudamed published a revised Service Entity Model XSD, UML diagram and samples which our team will review in detail.

Additional announcements are expected, so we’ll be sure to keep you posted.  In fact, we suggest bookmarking this blog page (better yet, subscribe!) so that you won’t miss a thing.