A Comparative Study of the Regulatory Requirements in European Union and United States for Medical Devices.
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Authors
Suresh, Neenu
Issue Date
2023-07
Type
Thesis
Language
en
Keywords
Alternative Title
Abstract
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.