MedTech News

EUDAMED: Two More Years

An important component of Medical Device Regulation (MDR), the launch of EUDAMED, has been postponed by two years to May 2022. However, May 2020 remains the date for the other elements of the MDR. It was considered unlikely that the deadline for the MDR would be postponed. However, the European Union now announced that at […]

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20+ important terms about MDR/UDI

The medical device industry does not have much time left to implement the regulatory requirements of the Medical Device Regulation (MDR). By enforcing such complex regulations, there is a need for clarity on what´s meant by the various terms. Alone in the numerous provisions of the UDI regulations, many expressions need to be known. We […]