Course description
Understanding Labelling and UDI for Medical Devices and IVDs (LIVE online)
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.
On this course 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.
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Upcoming start dates
Suitability - Who should attend?
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:
- Regulatory affairs
- Quality
- Project managers
- Product launch team
- Design and development team
Training Course Content
- Examine the labelling requirements under the new MDR / IVDR
- Fully understand the UDI requirements and explore strategies for implementation
- Assess labelling for specific cases such as single use, sterilisation and storage temperatures
- Navigate the new usability requirements and IFU
- Compare the new labelling requirements with MDD / IVDD
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5