Masterstudiengang "Drug Regulatory Affairs"

Master-Thesis

A review of the regulatory framework for Drug-Device Combination Products in Europe and the implications of the Medical Device Regulation (EU) 2017/745 implementation ***

Berit Frei (Abschlußjahr: 2024)

Summary
Language: English
The revision of the medical device law with replacing Directive 93/42/EEC by the new Regulation (EU) 2017/745 (Medical Device regulation, MDR) changed the requirements for medical devices dramatically. This did not only have an implication on standalone medical devices in Europe, but also on combination products incorporating a medical device and a medicinal product component. The so-called ‘Drug-Device Combination Products’ (DDCPs) fall under MDR requirements as well as the medicinal products law currently regulated under Directive 2001/83/EC. DDCPs include various products, where the medical device can either form a single integral product with the medicinal product or is required for administration of the medicinal product and co-packed or referenced.
This thesis reviews the current legislative framework for DDCPs and analyses the implications of the new MDR requirements for combination products in the EU. The investigation is completed by an empirical evaluation of the impact of MDR implementation for DDCPs conducted among industry members working with combination products. Finally the currently proposed revision of the European general pharmaceutical legislation is compared with the existing provisions for DDCPs to determine the significance of this statutory change for combination products.
The objective of the thesis is to determine the present status of implementation of MDR requirements for combination products in the EU, to outline uncertainties regarding interpretation and point out possible challenges for manufacturers of DDCPs.
Based on the investigations in this thesis it could be demonstrated that the revision of the medical device legislation with the obligation to implement the new MDR requirements has had a major impact on DDCPs. In the review of the regulatory framework and the empirical investigation of the impact of MDR implementation it has become evident that there are still challenges with the implementation of the MDR for manufacturers of DDCPs and a lack of clarity on the interpretation of the legislation is remaining as the legislation is not specifically designed for combination products. The proposed revision of the general pharmaceutical legislation in the EU from 26th April 2023 will not change this situation fundamentally.
Uncertainties on the interpretation of MDR requirements for DDCPs due to missing consistent definitions and detailed regulatory requirements can result in contrasting views of different competent authorities and notified bodies within the EU. It would therefore be desirable to improve the legislation and soft law on combination products to provide clear provisions for combination products. Manufacturers of DDCPs will need to become more familiar with the requirements resulting from the MDR and implement them in a pragmatic and compliant way. This could help to resolve the outstanding challenges on the implementation of MDR requirements for Drug-Device Combination Products, which play an important role in our health care system for the administration of many medicinal products and an improved treatment of patients.
Pages : 63
Annexes : 2, Pages : 37