The industry continues to see a significant shift away from small molecule drugs toward more complex drug molecules, such as biologics. Simultaneously, there is a trend towards an increased use of medical device technologies specifically in the area of administration systems to reduce the burden on healthcare payers, providers and patients. European regulators increasing safety and performance concerns is the driving factor for additional oversight when combining drug formulations with integrated or non-integrated delivery devices. Understanding the medical device design and how it forms integral and non-integral drug device combinations (DDC’s) is critical to navigate the new European regulatory landscape.

While Article 117 of the Medical Device Regulations (MDR) 2017/745 is not extensive, it is having a major impact on medical device and integral drug-device combination products manufacturers. Additionally, the European Medicines Agency (EMA) draft Guideline on the quality requirements for drug-device combinations provides additional insight for integral and non-integral DDCs data required in European marketing authorization applications (MAAs).

Examples of these expectations will be presented to outline the overall impact of Article 117 and additional elements of the MDR 2017/745 pertaining to combination drug products as regulated within the European community.

Featured Speakers

Mark Chipperfield

Independent Consultant

Mark has 20+ years in operational and senior roles (GSK, sanofi, Novartis, Roche). Working with different combi products (PFS/pens/AI, patch, pMDI/DPI, kits), has deep experience with execution (due diligence/technical evaluation, design control phases to market; industrialisation; in-market maintenance; change and issues management) whilst in parallel establishing right-sized operational frameworks including business processes; QMS; org structure; facilities, etc.

Kevin Lentz

Sr. Director, Regulatory Affairs
West Pharmaceutical Services, Inc.

Kevin Lentz currently serves as Sr. Director of Regulatory Affairs at West. In this role, Mr. Lentz leads global regulatory activities related to medical devices and delivery systems. He is responsible for providing strategic direction and guidance for development and commercialization of West’s medical devices and their customer’s combination products. Over the course of Kevin’s career, the diversity of his experiences has provided him with an in-depth understanding of the regulatory challenges associated with developing, and commercialization of medical devices and combination products. These experiences have enabled him to effectively work across multiple geographies with teams and customers to achieve business objectives to bring new medicinal products to market.

Mr. Lentz joined West in 2009 with 15 years’ experience working within small to large medical device organizations. During this period Mr. Lentz held positions of increasing responsibilities in areas of, quality assurance, and regulatory affairs supporting the development, registration and post approval activities for implantable and disposable medical devices. Mr. Lentz holds a Bachelor of Science degree in Chemistry from York College of Pennsylvania.

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