Abstract: The new EU Medical Device Regulation took effect on May 26, 2021, and introduces a stringent regulatory framework for medical devices in Europe. The aim of this research was to describe the changes that occurred with the implementation of the EU MDR Regulation and discuss the top challenges that …
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Abstract: The new EU Medical Device Regulation took effect on May 26, 2021, and introduces a stringent regulatory framework for medical devices in Europe. The aim of this research was to describe the changes that occurred with the implementation of the EU MDR Regulation and discuss the top challenges that regulatory and vigilance professionals are facing when implementing those requirements into the post-market surveillance and vigilance reporting processes. The research objective was to address three research questions: What has changed in regard to Post-Market Surveillance and Vigilance requirements with the release of the European Medical Device Regulation 2017/745? What are the main challenges experienced by regulatory affairs professionals in implementing new post-market surveillance requirements in the EU MDR Regulation? What are the main challenges experienced by MDR/vigilance professionals when implementing new vigilance requirements in the EU MDR Regulation? To address the research questions in depth, a literature review and a quantitive method approach were used. The practical research was conducted through quantitative questions with Regulatory Affairs Professionals, MDR Vigilance Professionals, and Subject Matter Experts in the Post Market Surveillance and Vigilance fields in Medtronic worldwide. The survey identified the primary challenges experienced by regulatory and vigilance professionals when implementing EU MDR requirements and strategy. This research provides valuable insight into the challenges experienced by regulatory and quality professionals to allow for more efficient planning of future MDR submissions for other product portfolios in the company and to continue sales of medical devices in Europe Key Words: ‘Regulatory Affairs’, ‘MDR Vigilance’, ‘Post-Market Surveillance’, ‘Vigilance’, ‘regulatory framework’, ‘challenges.Table of Contents 1 Chapter 1 Introduction1.1 Introduction1.2 Scope of Research1.3 Aim of the Research2. Chapter 2 Literature Review2.1 Introduction2.2 Post-Market Surveillance2.2.1 Overview of the new PMS requirements in European medical device market2.2.2 The post-market surveillance plan2.2.3 Post-market surveillance reports/ Periodic Safety update report2.2.4 Post market clinical Follow up2.2.5 Summary and Safety Clinical Performance2.2.6 Economic Operators2.2.7 Eudamed2.3.0 Clinical evaluation Process2.3 Vigilance2.3.1 Vigilance Key Requirements2.3.2 Reporting of incidents and field safety corrective action2.3.3 Manufacturer Incident Report (MIR)2.3.4 Analysis of Trends2.3.5 IMDRF Code Overview2.3.6 Person Responsible for Regulatory Compliance2.3.8 UDI2.4 Impact of the study.3. Chapter 3: Methodology3.1 Introduction3.2 Objective of the Research and Research Questions3.3 Research Methodology3. 4 Quantitative research3.5 Qualitative research3.6 Research strategies3.6 Literature Review3.7 Questionnaire design3.9 Puporse of the Survey3.10 Intended Audience3.11 Sample Size3.12 Questions type3.13 Data collection4. Results4.1 IntroductionSurvey 1. EU MDR: Challenges encountered in MedTech Sector related to Regulatory Affairs Specialist working in Post Market Surveillance Sector.4.1.1 Survey Qquestion 1 Results4.1.2 Survey Question 2 Results4.1.3 Survey question 3 Results4.1.4 Survey Question 4- Results4.1.5 Survey Question 5 Results4.1.6 Survey Question 6 Results4.1.7 Survey question 7 – Results4.1.8 Survey Question 8 – Results4.1.9 Survey Question 9 – Results4.2 Survey two - EU MDR: Challenges encountered in MedTech Sector related to MDR Vigilance Specialist working in the complaint Handling Sector.4.2.1 Survey Question 1- Results4.2.2 Survey Question 2 – Results4.2.3 Survey Question 3 – Results4.2.3 Survey Question 4 – Results4.2.4 Survey Question 5 – Results4.2.5 Survey Question 6 – Results4.2.6 Survey Question 7 – Results4.2.7 Survey Question 8 – Results4.2.8 Survey Question 9 – Results4.2.8 Survey Question 10 – Results5. Discussion/Analysis5.1 Survey 1 Analysis & Discussion5.1.1 Question 15.1.2 Question 25.1.3 Question 35.1.4 Question 45.1.5 Question 55.1.6 Question 65.1.7 Question 75.1.8 Question 85.1.9 Question 95.2 Survey 2 Analysis & Discussion5.2.1 Question 15.2.2 Question 25.2.3 Question 35.2.4 Question 45.2.5 Question 55.2.6 Question 65.2.7 Question 75.2.8 Question 85.2.9 Question 95.2.10 Question 105.3 Research Question 1.5.3.1 Vigilance System5.4 Research Question 25.5 Research Question 36. Conclusion6.1 Future work7. ReferencesAppendix 1 Survey Monkey Questionnaire 1Appndix 2 Survey Monkey Questionnaire 2Appendix 3 Survey EmailAppendix 4: Acronyms
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