Demystifying Challenges for IVDR Compliance | HCL Whitepaper


The current whitepaper is based on the enforcement of IVDR regulation in European Union . It defines the things which are still pending for a concreate decision or are still unclear to the manufacturers. The white paper has considered all aspects of processes that are currently followed by the manufacturers to manage the implementation of IVDR. The paper discusses about the technical difficulties and possible way or resolving them in relation to the additional performance studies requirements , technical file organization and post market safety planning