Clinical Investigations under EU MDR and the increasing need for Research Personnel | HCL Technologies

Clinical Investigations under EU MDR and the increasing need for Research Personnel

Clinical investigations play a huge part in procuring clinical evaluation (CE) mark, the MDR has significantly changed several aspects of the process with patient safety as the forefront mission. The main objective of any clinical evaluation is to demonstrate the safety and performance of a medical device in its clinical use. However, the expectation for clinical data has significantly increased with the transition from MDD to MDR. Precise clinical evidence for implantable & Class III devices as well as a systematic evaluation of class IIa & Class IIb devices are the two major changes that this new regulation is bringing to the medical device arena. Sponsors, investigators, monitors, and other personnel involved with the clinical investigation need to comply with regulatory requirements, standards and guidelines. There is a strong need to identify and place qualified personnel from the planning stage to the close-out processes.

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