Please use this identifier to cite or link to this item: https://www.um.edu.mt/library/oar/handle/123456789/88505
Title: Quality in medical devices
Authors: Odibei, Daniel E. (2021)
Keywords: Medical instruments and apparatus -- Law and legislation -- European Union countries
Product safety -- Law and legislation -- European Union countries
Standardization -- Law and legislation -- European Union countries
Compliance
Issue Date: 2021
Citation: Odibei, D.E. (2021). Quality in medical devices (Master's dissertation).
Abstract: Medical devices play an important role as a determinant of clinical outcomes in healthcare systems. Increased incidences of diagnostic errors gave rise to the need to further regulate and standardize diagnostic equipment. In a bid to further regulate the quality of medical devices placed in the European market, the European parliament replaced previously existing Directives1,2 for medical devices with new Regulations3 guiding placement of medical devices in the European market. While studies have established the incidences of diagnostic device errors, others have tried to establish causes of medical devices adverse events. This study aims to assess the quality of applications for medical devices to be put on the market and determine the impact of non-compliance with Medical Devices Regulation on the end users. The study made use of a retrospective analysis of applications received spanning a six month period between September 2020 and February 2021 by the Medical Device Unit of the Malta Medicines Authority for marketing authorization of medical devices in the European Union. The classification of non-compliant devices into low, moderate and high risk were based on the category or class of the device using the Medical Device regulation. Out of 195 applications received during the observation period, 172(88%) of the applications were classified as compliant, while 23 (12%) failed to meet the EU Directives on Medical Devices and therefore classified as non-compliant. The applications classified as noncompliant were able to comply within the given period of 7 working days as stipulated by internal procedures. Review of applications classified as non-compliant showed that the severity of non-compliance was low and ranged from missing information on Declaration of conformity, disparity on the intended use between the application form and Declaration of conformity submitted. Findings from this study indicated an increase in the number of compliant applications as the period progressed. There were no established patterns of noncompliance of applications for the different device classes. The result of the study indicated that most device manufacturers comply with the standards and requirements stipulated in the Medical Device Directive (MDD) and In vitro Diagnostic Device Directive (IVDD) for marketing authorization within the EU single market economy. Further studies can be done to corelate the number of applications compliant to the new EU Medical Device Regulation (MDR) and In vitro Diagnostic Device Regulation (IVDR) which come into effect from May 26th, 2021 and May 2022 respectively as a determinant of the level of preparedness of manufactures or wholesalers for the new Regulations.
Description: M.Pharm.(Melit.)
URI: https://www.um.edu.mt/library/oar/handle/123456789/88505
Appears in Collections:Dissertations - FacM&S - 2021
Dissertations - FacM&SPha - 2021

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