Original presentation date: September 2019

Overview

This webinar will provide an overview of labelling requirements according to the Medical Device Regulation (EU MDR). Participants will gain insights that will enable them to efficiently navigate the MDR requirements when it comes to the wide range of labelling items and helps them facilitate a decision-making process in the area of device labelling.

Learning objectives

This webinar will cover: 

• An overview of device labelling items
• Understanding the criticality of labelling
• Compliant labelling according to MDR
• Introducing the labelling relevant MDR sections and their impact on device labelling
• Safety aspects: warnings, data submission, periodic review
• Device identification and traceability: EU UDI and Eudamed
• Instructions for use, electronic Instructions for Use (eIFU)
• Language requirements
• Promotional material and advertising
• MDR compliance on human factors and usability

Target audience

Regulatory professionals from beginners to experts from the medical device industry who want to expand their knowledge in the area of labelling.

Presenter 

Marketa Nabiany is a consultant, trainer and project manager for pharmaceuticals and medical devices in the area of product labelling and packaging through lifecycle management: regulatory, safety, quality, artwork, product development, manufacturing, marketing and promotional labelling, usability, readability, translation management.

CPD

This course offers 1 CPD hour for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

Price 

Members: £105+VAT

Non-members: £142.50+VAT

Access

Once you have purchased the webinar, you will receive an email from topclass@topra.org with a link to the webinar within one hour. Once received, simply click on the link in the email to access the webinar. You will have access to the webinar for six months from the day of purchase. 
Please note, if you select the pay later option, you will not have access until payment has been cleared.

Terms and conditions

Please read the training terms and conditions before booking this webinar. By booking this webinar, you are agreeing to the terms and conditions.