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Informa
Starting 5 - 8 October 2020

LIVE Online Course - 4 sessions

Learn the labelling and UDI requirements under the new MDR/IVDR and develop strategies for successful implementation

Book with earlybird pricing now!

Receive 20% off if you book before 28 September

Course Overview

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 to important areas/departments like PMS and design development and how these areas can influence the label.

Live Online Academies

Gain real-time access to a subject matter expert delivering online training in a structured virtual classroom environment. Live online academies are virtual versions of some of our most popular face-to-face courses, delivered in bitesize sessions of 1.5-3 hours online.

Over 2 weeks students will learn through:

  • Live interactive bitesize sessions
  • Direct interaction with the trainer during live sessions
  • Participation in interactive features within sessions including polls, Q&A, break out rooms, tasks, case studies, and more
  • 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 lifesciences-training@informa.com.

What will you learn?


The MDR & IVDR
The MDR & IVDR

Examine the labelling requirements under the new Medical Device Regulation (MDR) and In-vitro Diagnostic Medical Device Regulation (IVDR)

UDI requirements
UDI requirements

Fully understand the UDI requirements and explore strategies for implementation

Labelling
Labelling

Assess labelling for specific cases such as single use, sterilisation and storage temperatures


IFU requirements
IFU requirements

Navigate the new usability requirements and IFU

How the requirements have changed
How the requirements have changed

Compare the new labelling requirements with MDD / IVDD

Who is this course for?

This interactive 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

CPD Certified

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.