As the Medical Devices and IVD industries transition to the new Regulations, organisations must implement new processes across a wide spectrum of regulatory areas to remain compliant. Labelling is one of these areas which has undergone a change in requirements and now includes Unique Device Identification (UDI) and expanded content requirements.
Over 2-days you will explore the new requirements, cross examining them with the requirements of the Directives. You will deep dive into the UDI requirements, fully understanding what is needed on the label and how it links up with the new EUDAMED database. Crucially, you will develop strategies to transition to the new labelling requirements, considering supply chain issues and Notified Body concerns. You will also explore how labelling is connected important areas/departments like PMS and design development and how these areas can influence the label.
Richard Young has over 20 years’ experience in the medical device industry with products such as class 3 implants to electromedical infusion systems. Richard has extensive experience in regulatory affairs, GMP (quality), GLP (laboratory testing) and clinical affairs. Richard has held various positions within industry such as QA/RA Manager and Director, Quality Assurance and Regulatory Compliance at various companies including Biomet, Plasma Surgical and Zimmer Limited.
This 2-day course is aimed at regulatory professionals who are involved in device labelling and require a comprehensive understanding of the requirements under the MDR to ensure compliance. These include: