A Comparative Study of the Regulatory Requirements in European Union and United States for Medical Devices.

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Suresh, Neenu
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BACKGROUND: There were many debates concerning the regulatory requirements in the United States and European Union for medical device in terms of quality, efficacy and safety. The aim of the study is to compare the regulatory requirements for medical devices in the European Union and United States. This study looks at the differences between these two regulations, post marketing surveillance tools used, reasons for medical device failures after the approval from the regulatory authority and finally the areas of regulations that requires improvement. The purpose of the medical device regulations is to constantly provide safe, effective and efficacious medical devices and taking care of the public health. METHODS: Research was conducted using scholarly articles, peer-reviewed journals from PubMed and Google Scholar. Most recent articles of less than 10 years were used to conduct literature search. A survey was also conducted using a questionnaire which comprised of 26 questions with 40 responses which consisted of 5 sections with closed and open-ended questions. FINDINGS: There were not that many differences in the 2 regulations other than differences in the execution of the different processes for example in classification and approval pathway of the regulations. Post marketing surveillance enhancement is another area which requires improvement. Healthcare professionals, manufacturers and patients must be encouraged to report any adverse effects from the devices and upload them to the database. To prevent recalls in the medical device industry the behavior of the medical devices must be observed and studied in different environments and conditions and harmonized collection events must be set up in place that is evidence based. CONCLUSIONS: The research gives more insight to the regulatory framework of EU and US for the policymakers. Both systems have their own pros and cons. It is difficult to say that one system outweighs the other. Both the system suggested that more clinical data and quality system management are required for the effective and safe approval of devices. There must also be increased participation for adverse events reporting from various stakeholders for effective post marketing surveillance. All these contribute to reduction in medical device failures.
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