PubMed · 4050941
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T Hamano, Y Ohashi, Y Cho, Y Shimomura, R Manabe. 1985-10-15. A new punctum plug.. https://doi.org/10.1016/0002-9394(85)90698-1
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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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The U.S. DOE Pantex Plant has been given the mission to recertify and requalify plutonium pits for reuse in existing War Reserve nuclear weapons. The first process common to both recertification and requalification is cleaning the plutonium pit. The pit will be cleaned in a dissolution vessel using N-methyl pyrrolidone (NMP) solvent. The recertification and requalification programs are both in the design concept phase at Pantex Plant The U.S. DOE Pantex Plant secures the national security of the United States by using safe vessels for cleaning plutonium pits in a manner that protects the health and safety of employees, the public and the environment.