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Implant related data set developed to address requirements of new EU MDR

University Medical Center Schleswig-Holstein and Stryker Trauma GmbH laid ground for addressing the new EU Medical Device Regulations (MDR) and, thus, for future hospital-industry research and innovation (R&I) collaboration by defining an implant related data set.
The MDR feasibility study, which is embedded into the complications pilot, aims to utilise BFCC registry data with the purpose to address the new EU Medical Device Regulations (MDR). It is the goal that registered implants can be directly matched with clinical and device related complications if they occur. By altering the in-hospital IT infrastructure it may be possible to directly extract the data of the hospital and transfer it to the registry database. As one major important step, the partners now agreed to an implant specific minimal data set that contains the implants article numbers which can be captured with a barcode scanner and the occurrence of device related adverse events.

 

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