The Six EUDAMED Modules (MDR)

Overview of the 6 EUDAMED modules (MDR)

An important component of the MDR and IVDR is the EUDAMED. As a central database, it is intended to create more transparency, bundle information, and serve as an exchange and reporting platform for the individual actors. To this end, it consists of six modules that cover various topics ranging from the registration of medical devices […]

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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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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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