What’s New?

EUDAMED go-live date is still scheduled for May 2022.  But you may recall that in order to ensure a smooth and effective implementation, the EU Commission provides a “EUDAMED playground.”  It’s currently available for both manual web-based user access, and an automated M2M (machine‑to‑machine) Data Exchange for Actor Registration, Notified Bodies (NBs) and Device Registration modules.  The Market Surveillance and Clinical Studies & performance modules will be added to the playground later in 2021.

We’re happy to advise that as of 31 March 2021, the EU Commission’s DG Sante has deployed and made available to Economic Operators and Notified Bodies, the latest EUDAMED playground  (PG 1.1)for Device Registration and NBs & Certificates modules.  This new playground is the first release from DG Sante and replaces the previous releases provided by DG Grow.  This new playground will enable Economic Operators (including manufacturers, authorized representatives, importers and system/procedure pack producers in the field of Medical Devices and In Vitro Diagnostic devices) with several new capabilities for submitting medical device data. 

Is there a specific schedule?

As of this writing, the EU Commission has outlined the following Playground schedule:

Release 1.1 Playground – 31 March 2021 – deadline for feedback is 30 April.

o    Upload information:  Basic UDI-DI and UDI-DI

o    Downloadable information:  Basic UDI-DI, UDI-DI and device data (no version data)

o    Includes Legacy Devices

 Release 1.2 Playground – 30 July 2021

o    Download Refused certificate       

o    Download issued Certificate (no version data)

o    Add new UDI-DIs for existing Basic UDIs 

o    Download SSCP (Summary of Safety and Clinical Performance)

 Release 1.3 Production –  September 2021

o    Update Basic UDIs / EUDAMED DI

o    Update UDI-DIs / EUDAMED ID

o    Add/Update Market Information (tbc)

o    Add/Update Container Package (tbc)

What is the impact?

Testing is critical to the success of EUDAMED, so as an active participant and contributor, Innovit* is very pleased to continue this process following our earlier success dating back to October 2019.  Early access and testing of M2M data exchange in the EU Commission’s playground was – and still is – critical to the success of EUDAMED.  This collaborative testing process gives us the opportunity to provide technical feedback to the EU Commission’s development team (DG Sante), to help them improve system design as well as uncover problems or potential issues.  Innovit’s development team can also make enhancements to our EUDAMED Connector software as needed from these QA activities.

I’m not an economic operator, what does the delay mean for me?

Although the launch of the EUDAMED Device Registration and Certificate modules were postponed from May 2021 to September 2021, manufacturers are advised not to use this extension as an excuse to defer making operational changes until just before the deadlines.  Rather, we recommend that you take this opportunity to properly prepare Regulatory Affairs and engineering operations for improved data compliance.

Innovit is here to help ensure that your product data are compliant in time for the upcoming EUDAMED deadline and we have experts on hand to ensure that your master data is prepared for validation and beyond.

Don’t just focus on the voluntary registration in the EUDAMED database, prepare for additional registration at a national level as well.

What’s coming next?

Innovit understands today’s immediate challenges facing the medical device industry.  So, we will continue to keep you updated as more information becomes available.

*(Reminder: Three solution providers – including Innovit – were invited to participate in this testing program.  Innovit has provided feedback for Testing Round 1 & 2 and continues its close collaboration.)