Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe

Livia Adalbert; S P Yamini Kanti; Orsolya Jójárt-Laczkovich; Hussein Akel; Ildikó Csóka

doi:10.3390/biomedicines10112947

Expanding Quality by Design Principles to Support 3D Printed Medical Device Development Following the Renewed Regulatory Framework in Europe

Biomedicines. 2022 Nov 16;10(11):2947. doi: 10.3390/biomedicines10112947.

Authors

Livia Adalbert¹, S P Yamini Kanti¹, Orsolya Jójárt-Laczkovich¹, Hussein Akel¹, Ildikó Csóka¹

Affiliation

¹ Institute of Pharmaceutical Technology and Regulatory Affairs, Faculty of Pharmacy, University of Szeged, Eötvös Utca 6, H-6720 Szeged, Hungary.

Abstract

The vast scope of 3D printing has ignited the production of tailored medical device (MD) development and catalyzed a paradigm shift in the health-care industry, particularly following the COVID pandemic. This review aims to provide an update on the current progress and emerging opportunities for additive manufacturing following the introduction of the new medical device regulation (MDR) within the EU. The advent of early-phase implementation of the Quality by Design (QbD) quality management framework in MD development is a focal point. The application of a regulatory supported QbD concept will ensure successful MD development, as well as pointing out the current challenges of 3D bioprinting. Utilizing a QbD scientific and risk-management approach ensures the acceleration of MD development in a more targeted way by building in all stakeholders' expectations, namely those of the patients, the biomedical industry, and regulatory bodies.

Keywords: 3D printing; customized medical device development; new medical device regulation and quality by design.

Publication types

Review

Grants and funding

This work was funded by Ministry of Innovation and Technology of Hungary from the National Research, Development and Innovation Fund, financed under the TKP2021-EGA funding scheme.