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 […]
It has taken four years for the British to finally leave after their referendum against remaining in the European Union. Despite the last-minute trade deal, the impact of Brexit on the Pharma and Medtech industries is huge, and they are left with only a little concrete information. In 2016, just over half of the Britons […]
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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. Corresponding initiatives are either being worked on or are in the planning phase. The WHO and other organizations […]
A single point of truth (SPOT) for data or document management is a must in highly regulated markets combined with increasing digitalization. Even small and mid-sized companies can hardly avoid this if they want to keep up with the market. Therefore, it is important to consider the advantages of a centralized data management system. There […]
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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 […]
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 […]