Training Course: Understanding Labelling and UDI for Medical Devices and IVDs
Gain a comprehensive understanding of the labelling and UDI requirements under the new EU MDR & IVDR and develop strategies for successful implementation
As the Medical Device and IVD industries transition to the new EU MDR and IVDR 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 to important areas/departments like PMS and design development and how these areas can influence the label.
What will you learn?
The MDR & IVDR labelling requirements
Examine the labelling requirements under the new Medical Device Regulation (MDR) and In Vitro Diagnostics Regulation (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
The changing regulatory landscape
Compare the new labelling requirements with MDD / IVDD
Who is this course for?
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 EU MDR and IVDR to ensure compliance. These include:
- Regulatory affairs managers
- Project managers
- Product launch team
- Design and development team
Meet The Trainer
Richard Young, Technical Director, SENSUS Group
Richard Young has over 20 years’ experience in the medical device industry, working with products from Class III implants to electromedical infusion systems. He 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.
Engaging in Continuing Professional Development ensures that both academic and practical qualifications do not become out-dated or obsolete; allowing individuals to continually ‘up skill’ or ‘re-skill’ themselves, regardless of occupation, age or educational level. This course has been assessed and is CPD certified.
Live Online Academies
Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. MedTech Series online training courses are live courses developed by our expert faculty providing learning on a range of technical topic areas.
Students will learn through:
- Direct interaction with the trainer
- Revisiting recorded sessions with unlimited access for 30 days
- Interaction with peers during live sessions and through the online forum
Timings and dates are subject to change - final confirmation will be provided with login details. Delegates will receive login instructions within a week of the course start date. If you have any questions please contact email@example.com