One of the current greatest challenges for manufacturers of medical devices in the European Union is the implementation of the new legal framework: the Medical Device Regulation (MDR) and the In Vitro Diagnostic Device Regulation (IVDR).
The basic focus of the new regulations is on strengthening patient safety and improving data transparency. This is accompanied by profound changes that range from the documentation of clinical data to the mandatory introduction of the Unique Device Identification (UDI) system.
Despite the frameworks already in effect from 2020, a majority of manufacturers do not yet feel adequately informed, which, for example, can even lead to the loss of approval of medical devices for the European market if there is a lack of compliance.
In order to shed light on all aspects of the restructured regulations, we at Capgemini have summarized the most important information for our customers in order not only to give you an overview of the changing circumstances but also to show potential solutions.