PubMed · 13799925
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W L BERSON, T V RICHEY. Headlight.. https://pubmed.ncbi.nlm.nih.gov/13799925/
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BACKGROUND: This research aims to assess the current impact of the medical and in-vitro diagnostic devices regulations (MDR/IVDR) on the device industry in the EU, under the lens of postimplementation and the amending regulation, and in advance of the final transition to the IVDR/MDR in the future. RESEARCH DESIGN AND METHODS: A quantitative survey was administered to a diverse cohort of medical device enterprises, ranging from micro to large organizations. RESULTS: The survey indicates that the MDR/IVDR has harmed innovation, leading many manufacturers to seek initial device approval and launch elsewhere before in Europe. There is evidence that some manufacturers have rationalized their existing product portfolios and removed devices from the market as they stated they would in previous industry surveys. The MDR/IVDR has been shown to negatively impact manufacturers, with increased costs related to notified body (NB) fees, maintaining and updating documentation, recertification fees, and hiring additional staff. CONCLUSION: This study provides a current status of the effects of MDR/IVDR on manufacturers and finds that despite amending regulations and other interventions taken by the EU to mitigate regulatory burden, ensure product availability, and address stakeholder concerns, the EU is no longer the market of choice for new products.
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Numerous medical devices are used in the chest and fewer in the abdomen and pelvis. They are frequently seen on various radiological studies in daily practice. Knowing the specific name of the device is not important. However, knowing the proper positioning and function of the device is necessary. It is a duty of the reporting radiologist to recognize the malpositioning or breakage of a medical device and to inform the responsible physician promptly, since these complications can have undesirable consequences and sometimes a fatal outcome.