PubMed · 13692801
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R CHENKOV. 1961. [A pupillometer].. https://pubmed.ncbi.nlm.nih.gov/13692801/
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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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Examination of the reliability and validity of research tools is an important process in nursing research. As all scales are developed on the basis of a specific set of concepts or application to a specific population, great care must be taken in the translation and handling of questionnaires developed in different languages or, in particular, by people from different cultures. Only after passing through an integral process of repetitive translation and reliability/validity examinations can they be regarded as accurate research tools and be widely utilized. This study exercises Brislin's revised Translation Model to overcome cross-cultural differences, and also uses a new research tool developed overseas, the Diabetes Management Self-Efficacy Scale (DMSES), as an example for explaining the two-stage design of the translation and reliability/validity process. The First Stage is the translation stage, which involves forward translation, consensus meetings, backward translation, and review by potential users. The Second Stage involves psychometric analysis, which includes validity and reliability testing. Such careful processes should reveal the problems encountered when adopting foreign scales for domestic use, and thereby increase the "nativeness" and adaptability of these scales.