MDR for Manufacturers

MDR for Manufacturers

Just three years ago, a deadline extension for the MDR implementation was under discussion, which was desired above all by the manufacturers. The deadlines remained unchanged, which was quickly determined. However, the question of how to stem the upheaval in the medical technology industry remained unanswered. The biggest concern is probably the lack of notified […]

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20+ important terms about MDR/UDI

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 […]

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All About the UDI Regarding MDR

The Medical Device Regulation (MDR) is an EU directive that will come into force on 26 May 2021 and represents a further large-scale industry revolution. In addition, to some reclassifications and high demands on data management, Unique Device Identifiers (UDI) on medical devices will also become mandatory. The USA introduced UDI labeling as early as […]

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