In this expert discussion, Brian Cleary is joined by Marie O'Callaghan and Susanne Weps to examine the practical regulatory and development challenges facing combination-product teams in the European Union.
The discussion explores how the growth of advanced therapies is increasing demand for more sophisticated drug-delivery systems and how EU MDR requirements affect the device components of medicinal products. It examines the importance of MDR Article 117, early engagement with notified bodies and the differences between pharmaceutical and medical-device development.
It also considers the role of usability engineering, risk management, design controls and traceability, alongside the additional work that can arise from changes to materials, suppliers, formulations or device components. The central message is that drug and device development should not be treated as separate processes brought together at submission, but as one integrated product that must be developed, assessed, documented and justified accordingly.
To discuss your combination-product development, EU MDR, Article 117, usability, or regulatory strategy with NSF Life Sciences, contact: lifesciences@nsf.org
