EU MDR Implications on Medical Device Labelling and

EU MDR Implications on Medical Device Labelling and
This two-part webinar will provide an overview of labelling requirements according to the Medical Device Regulation (EU MDR).

When: Available on demand. (Originally presented in 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

The webinars will cover: 

  • An overview of device labelling items
  • Understanding the criticality of labelling
  • Compliant labelling according to MDR
  • Introducing the labeling 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. 

Speaker

Marketa NabianyMarketa 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 2 CPD hours for successful completion, to learn about why CPD is important visit the Lifelong Learning page.

How do I register?

Simply log in or create an account and register below. 

Prices

Type Member  Non-member 
Standard    £105 + VAT £142.50 + VAT 
 

Discounted Places

A limited number of discounted places are available at the rates below for those:

Please email meetings@topra.org for a discount code before making your booking.

Type Member  Non-member 
Discount  £35 + VAT*  £47.50 + VAT* 


* VAT, if applicable, is charged at a rate of 20%.

Terms and conditions

By purchasing this webinar, you are agreeing to the terms and conditions. 
When
17/09/2019
Where
At Your Desk Europe ONLINE
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