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.…
Archives 2021
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…
UDI overview in Asia
Marked by strong economic development, Asian countries are gradually implementing UDI and regularizing their regulatory environment for medical devices. It is therefore smart to know where these countries are in…
Details on Storage/Handling conditions and Critical warnings
Which details of the critical warnings have to be provided to EUDAMED, to the GUDID ? The Label information, the instructions for use, or both ? What about the contra…
UDI World Overview July 2021 status
The UDI (Unique Device Identification) field is still evolving and is more or less advanced depending on the country. If you are in any way related to the medical devices…
Kern Experience webinar: Master Data Management of the EU MDR in SAP
Our partner Kern AG organizes a free of charges webinar on July 21, 2021 with the participation of Ismail Demiralp as guest lecturer, the CEO of Europe IT Consulting GmbH.Since…
New requirements for Switzerland
New differing requirements now apply to EU and Swiss medical device manufacturers.As already mentioned in a previous article (MRA between Switzerland and EU no longer valid), Switzerland is considered as…