Masterarbeit

Harmonization of Regulated Product Submissions for Medical Devices - International Medical Device Regulators Forum Table of Content concept

Dr. Anja Kassner (2016)

Summary
Language: english
The harmonization of regulated product submissions for health care products has a proven beneficial history based on the experiences from definition of the Common Technical Documentation (CTD) format for medicinal products by the International Conference of Harmonization (ICH) since 2000.
This thesis deals with the ongoing approach to achieve harmonization of regulated product submission for medical devices by placing particular emphasis on the Table of Contents (ToC) concept presented by the International Medical Device Regulators Forum (IMDRF) in 2015. Following an introduction of the IMDRF organization and its work topics and achievements of the past five years, the new concept for harmonized regulated product submission will be compared to the past approach, which is the Summary of Technical Documentation (STED) as published by the predecessor of IMDRF; the Global Harmonization Task Force (GHTF). In addition, this thesis will also compare the ToC concept to current recommendations by selected IMDRF members regarding the structure of premarket application submissions.
Finally, this thesis will discuss whether the ToC concept effectively supports the aim of the IMDRF work to support global regulatory convergence in regard to harmonized submissions for pre-market assessment of medical devices. The discussion will also take into account the ongoing global ToC pilot program and any available interim findings gathered from it. As an outlook into the possible future of the ToC concept as the new common format, this thesis will consider especially the current regulatory challenges associated with the implementation of the new Medical Device Regulation (MDR) in the European Union.
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