EUDAMED: How to update market information?
Perhaps you have already asked yourself which information should be entered in the EUDAMED database in the "Market Information" area. According to our request to the European Commission, the following…
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Visit to the “MedtechLIVE with T4M”
We visited MedtechLIVE 2022 in Stuttgart, were able to look at interesting new developments and meet customers and partners. The issue of EUDAMED and MDR seems to have moved into…
EUDAMED Database Update App-Version 2.7.0
On April 4th, the EUDAMED was updated. With this release, some known errors have been corrected, which were reported by Europe IT Consulting GmbH, among others. But the main innovation…
Switzerland launches its own medical device database
Switzerland will now create its own medical device database. What happened: Since the expiry of the MRA (Mutual Recognition Agreements) contract, which was not renewed with the EU, Switzerland is…
Release UDI EUDAMED Version V2022/02
The new EUDAMED UDI SAP add-on version V2022/02 has been released and now supports all important areas for data processing through to the generation of EUDAMED-compliant XML files. Significant adjustments…
New transition periods for IVD Products
Although the IVDR will still fully apply from 26 May 2022, the European Commission proposed additional transition periods to avoid any significant disruption in the supply of IVD medical devices.…
UDI/Devices and NBs & Certificates modules are open
BREAKING NEWS published by the European Commission: EUDAMED UDI/Devices and NBs & Certificates modules are open. Economic Operators and Notified Bodies can start entering data in EUDAMED on voluntary basis.…
EUDAMED will be unavailable for a few days
Are we getting closer to the UDI/Devices registration module go-live date? The European Commission posted an important information regarding EUDAMED on the official EC website on Wednesday 29, 2021. …
UK: MHRA launches a public consultation
Medical device actors can gives their views and contribute to the future UK´s regulatory framework. Since September 16, 2021, the Medical and Healthcare products Regulatory Agency (MHRA) gives the opportunity…
Submissions from NB now accepted for PECP
Submissions for PECP (Performance Evaluation Consultation Procedure) are accepted since September 3, 2021, by the expert panels in the field of in vitro diagnostic medical devices. What are the expert…