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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In focus: UDI international

In 2017, the European Commission launched the MDR and thus also the Unique Device Identification (UDI). Europe is not alone in this. The concern to make medical technology products safer is also being implemented in other countries with corresponding initiatives or is in the planning phase. The WHO and other organizations have been working for […]

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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 2020 (edit: postponed to 2021) and represents a further large-scale revolution in the industry. In addition to some reclassifications and high demands on data management, Unique Device Identifiers (UDI) on medical devices will also become mandatory. UDI labeling […]

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