Medical device Notified Bodies (NBs) work with many types of combination products. This session aims to discuss the combination products in scope of notified bodies and their regulatory requirements. This will cover Integral drug device combinations, regulated as medicines but…
Introduction - Definition of combinations products - Type of devices used in drug clinical trials - Regulatory pathway Clinical Trials with a CE-Marked device as delivery system - Clinical development of the DDC - Sponsor responsibilities Combined Studies - Definition…
As a person living with type 1 diabetes, I rely on combination products—an insulin pump and a continuous glucose monitor (CGM)—to manage my condition every day. These technologies have transformed diabetes care, offering better glucose control, fewer complications, and an…
The evolving regulatory landscape for Drug-Device Combination (DDC) products requires manufacturers to meet stringent safety reporting obligations under FDA (MedWatch, 21 CFR Part 4) in the USA and EU Medical Device Regulation (MDR; Regulation 2017/745, Article 117, and Notified Body…
As the MedTech industry continues to evolve, the importance of integrating patient perspectives throughout the medical device life cycle, including drug-device combinations, diagnostics and digital products, is becoming increasingly evident. In this talk, we will explore critical stages where patient…
The surge in the development of combined products, which integrate medicinal products, medical devices, and digital health technologies, presents significant challenges for pharmaceutical companies. The lack of a harmonised regulatory framework across different jurisdictions complicates the efforts, while the awareness…
Medical device–medicinal product combinations, where the primary mode of action is attributed to the device, are regulated under medical device regulations. This presentation offers a comprehensive overview of the relevant regulatory landscape, with a particular focus on Europe. It also…