Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

MDR's Article 117: Regulatory Strategy to Comply With the General Safety and Performance Requirements Set Out in Annex I in the Light of a Single Integral Drug Device Combination ***

Caroline Schommer (Abschlußjahr: 2019)

Summary
Language: English
Innovative medicinal products are often presented in the format of single integral Drug Device Combinations (DDCs) such as pre-filled syringes. Accordingly, DDC marketing authorisation applications submitted by pharmaceutical companies are increasing. Special attention should be drawn to the publication of the Medical Device Regulation (MDR) (Regulation (EU) 2017/745) that amends by its Article 117 the Medicinal Product Directive (Directive 2001/83/EC). As a consequence, the marketing authorisation applicant has to submit a notified body opinion on the medical device part of the single integral DDC. A positive opinion is reached by demonstrating compliance with MDR’s Annex I listing the General Safety and Performance Requirements (GSPRs). This master thesis brings the relevant changes in legislation to the attention of the interested reader and outlines significant consequences of Article 117 in the context of single integral DDCs. A case study on a pre-filled syringe was performed assessing the applicability of the GSPRs as well as how to demonstrate compliance with the requirements. Within the analysis, new requirements introduced by the MDR were highlighted appropriately. In addition, the GSPRs were mapped to currently existing requirements such as the Essential Requirements of the Medical Device Directive (MDD) (Directive 93/43/EEC) or established medicinal product dossier requirements as applicable. The subsequent discussion outlines which GSPRs are potentially captured by the current marketing authorisation application dossier and would contribute to a redundant review by the competent authority and the notified body. In addition, based on the outcome of the analysis, it can be concluded that there is a significant subset of new requirements introduced by the MDR. Some of them are seen as impactful and should be assessed carefully. In contrast, it can be also determined that many requirements reflect the current state-of-the-art and are aligned with generally recognized technical standards. Furthermore, previous Essential Requirements of the Medical Device Directive are modified including either expanding or updated subclauses. Nevertheless, it was found that another subset of requirements like clinical evaluation or labelling are still unclear in the context of a single integral DDC as of now unless further guidance is published.
Pages: 56, Appendices: pages: 21