Raga Padmasri Deepika Majety, Sujatha Katru, Jaya Prakash Veluchuri*, and Ravi Kumar Reddy Juturi
In Europe there are very high expectations regarding the quality, safety, and efficacy of medical devices. But in reality, it fails, due to many scandals that threatened the lives of thousands of people. So, the EU has introduced the new regulations in medical devices to meet the expectations. The old directives such as medical device directive (MDD) and active implantable medical device directive (AIMDD) are now replaced with medical device regulation (MDR), and in vitro diagnostic medical device directive (IVDD) is replaced with in vitro diagnostic regulation (IVDR). When compared to MDR there are more significant changes introduced in the IVDR. The New Regulations has a hard deadline for certifications and manufacturers cannot launch their product without certification, hence manufacturers have to meet the new regulations within the given time frame. The change in regulation brings a disturbance for the medical device industry. The manufacturers have to make strategic decisions to streamline their innovation pipeline and R&D processes in response to the increased cost of compliance and longer product certification time, so it is essential to conduct the SWOT analysis to evaluate the effect of new regulations. To bridge the gap between the new and old regulations, Gap analysis should be done. Gap analysis is used as a tool that helps to monitor the quality management system and is mainly useful where Standards and regulations are updated. This analysis may add value to reforming the portfolio. The regulatory authorities have to focus on the problems faced by manufacturers and try to resolve the issues as soon as possible.
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