Description EU MDR Article 117 fundamentally changes how medicinal products incorporating medical devices are evaluated for EU market access. We'll provide a practical overview of Article 117 requirements, including the role of Notified Bodies and the integration of device conformity into the medicinal product dossier. You'll gain clarity on regulatory pathways, documentation expectations, and common compliance challenges for combination products. Real‑world considerations will be discussed to support efficient development, submission, and ongoing lifecycle management.
Learning Objectives:
Explain the regulatory intent and scope of EU MDR Article 117 as it applies to integral drug–device combination products.
Identify the required Notified Body involvement, opinion types, and documentation needed to support a compliant marketing authorization application or lifecycle change.
Apply practical strategies to align pharmaceutical and medical device development activities to minimize regulatory risk and approval timelines.
