Investigation into the challenges encountered by regulatory affairs professionals working in the Medtech industry /

Abstract

This research focused on the challenges experienced by Regulatory Affairs professionals working in the Medtech industry. Initial brainstorming with regulatory colleagues who have greater than ten years’ experience identified three main challenges: 1 Different Regulatory Frameworks in different regions (lack of regulatory harmonisation across geographies) 2 Evolving Regulatory Frameworks/Requirements for example European Medical Devices Regulation (MDR) and the In Vitro Diagnostics Regulation (IVDR) 3 Staying informed on changing government policies/status and the impact this has on the Medtech industry for example Brexit

A detailed literature review yielded sufficient information for Europe and the United States however information regarding China, Korea or Japan was not easily obtained. A survey was conducted via SurveyMonkeyTM to Medtech Regulatory Affairs professionals located in Ireland which was designed to provide details on the following four research questions: 1 What is the main challenge experienced by Regulatory Affairs professionals in gaining regulatory approval in United States, Europe, China, Korea and Japan? 2 How are Regulatory Affairs professionals staying informed on changing and evolving global regulatory requirements? 3 How are the regulatory requirements communicated internally in companies by Regulatory Affairs professionals? 4 Are Regulatory Affairs professionals aware of changing government policies that impact the Medtech industry?

The survey identified that the main challenge experienced by Regulatory Affairs professional is the lack of regulatory harmonization across different geographies. The survey identified the tools and methods used by Regulatory Affairs professionals to stay informed on global regulatory requirements and changing and evolving regulatory requirements. The main method used by Regulatory Affairs professionals to communicate regulatory requirements is through project team meetings. This highlighted a tool that is possibly underutilised by Regulatory Affairs professionals, the regulatory strategy document. Regulatory Affairs professionals are not overly concerned by changing government policies. This research is useful as it provides insight into the challenges experienced by regulatory Affairs professionals working in the Medtech industry and supporting global jurisdictions.