Replacing the Medical Devices Directive (MDD) 93/42/EEC, the Medical Devices Regulation (MDR) 2017/745 will provide greater safety for patients and better transparency for all stakeholders. This webinar explained Article 117 requirements for single integral drug-device combination products.
Presented by Krystel Limouzin, Global Regulatory Affairs Director, Aptar Pharma and Andrew Wood, Associate Director, Regulatory Affairs, Aptar Pharma, this webinar explains the Article 117 requirements for single integral drug-device combination products, providing an overview of the current situation and the challenges ahead, from both the Authorities’ and Industry perspectives.
Replacing the Medical Devices Directive (MDD) 93/42/EEC, the Medical Devices Regulation (MDR) 2017/745 will provide greater safety for patients and better transparency for all stakeholders. Manufacturers need to comply for both existing and new technologies. This includes drug-device combination products that form a non-reusable, single, integral product exclusively used to administer the medicinal product, under the requirements of Article 117. Article 117 introduces the notion of risk-classification, and accordingly to involve a Notified Body as a new stakeholder in the medicinal product’s Marketing Authorization Application (MAA) process in Europe.
Back in 2019 the European Medicines Agency (EMA) published in draft guidance and Q&A. However, many questions remain, which we review during this webinar. The EMA is proposing a collaborative workshop across all stakeholders to help clarify Article 117 implementation and translate this into a final EMA guideline. This multi-stakeholder workshop is currently postponed due to the COVID-19 pandemic, so we share our current view on how to get prepared for Article 117.
Viewers will gain a greater understanding of the impact of Medical Device Regulation Article 117 on all stakeholders involved in a single integral drug-device combination product’s development, the approval process and lifecycle management.
Global Regulatory Affairs Director, Aptar Pharma
Krystel Limouzin is an engineer, having received her engineering degree in pharmaceutical sciences from the faculty of pharmacy of Montpellier, France, with a master’s degree in regulatory affairs from the faculty of pharmacy of Châtenay-Malabry, Paris, France. She has over 20 years of regulatory affairs experience in pharma, medical devices and container-closure systems/combination products environments. She started her regulatory affairs carreer in national and international pharmaceutical companies, and then moved to the container-closure systems and parenteral drug-delivery devices sectors. In the past years she was in charge of global medical regulatory affairs for an international medical company, and more recently in 2019, she joined Aptar Pharma as Global Regulatory Affairs Director, to manage the regulatory affairs teams and activities for Aptar Pharma globally.
Associate Director – Regulatory Affairs, Aptar Pharma
Andrew Wood has more than thirty years’ experience in the OINDP (Orally Inhaled and Nasal Drug Product) industry. Initially working as Quality Manager for a device manufacturing company, he then spent many years with a major pharmaceutical company as device technical support for development and launch of inhalation combination products. He joined Aptar twelve years ago as Associate Director for Regulatory Affairs, supporting many clients through regulatory approvals of OINDPs in all world markets.