Would the deceit practiced by the US diagnostic testing company, Theranos, have been uncovered any more quickly in the EU under the new In Vitro Diagnostic Medical Devices Regulation (IVDR)? This matter is considered by Ronald Boumans during a recent interview with Medtech Insight.
Regulatory bottlenecks and fears about product availability have been a feature of medical device regulation in the EU throughout the complicated transition to the Medical Device Regulations (MDRs). But might 2023 offer some respite? Five experts gave Medtech Insight their best guess.
2022 ended on as positive a note as could have been wished for in terms of setting the scene for a more effective implementation of the MDR. But has too much damage already been done?
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