February 21, 2022
The Medical Device Coordination Group issued a new guidance document: MDCG 2022-4 - ‘Guidance on appropriate surveillance regarding the transitional ...
January 24, 2022
Originally, EUDAMED was to be fully functional on 26 May 2020 and align with the MDR's original date of application, ...
December 21, 2021
The EU Commission published that EU Parliament and Council have adopted the proposed amendment to the IVDR, to push out ...
December 14, 2021
The EU Medical Device Coordination Group (MDCG) has released a new document related to the Importer (Art. 13) and Distributor ...
October 17, 2021
EUDAMED development is progressing further with the publication of two new modules: UDI/Devices registration and Notified Bodies & Certificates. With ...
October 15, 2021
Citing the COVID-19 pandemic and a ‘grave shortage of notified body capacity’, the EU Commission has proposed delaying implementation dates ...
March 26, 2021
The Medical Device Coordination Group (MDCG) published MDCG 2021-3: Questions and Answers on Custom-Made Devices & considerations on Adaptable medical ...
February 20, 2021
With MDR date of application fast approaching, there are still some unanswered questions related to the transition process for ‘legacy ...