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Focusing on the Details: MDR PART II - Translations Requirements

Now, language requirements are part of the MDR  - with a requirement that labeling must be in the national language and "clearly comprehensible to the intended user or patient".

This significant change will impact the way organizations approach translations.

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MEET THE SPEAKER

Yvonne Middlefell

Yvonne Middlefell
A highly experienced regulatory professional with more than 29 years’ experience in Global Regulatory Affairs, Quality and R&D, 
Yvonne Middlefell, RAC, FRAPS, is currently the Executive Director of Stellar Regulatory Consulting, LTD.  She has in-depth knowledge across a broad range of disciplines, including medical devices, in-vitro diagnostics, biologics, pharmaceuticals and OTC. Yvonne has written and submitted more than 30 510(k) submissions, PMAs, IDEs and BLAs and established RA functions for multinational organizations. She holds a 2:1 Hons degree in Science, Technology and Management from the Open University, United Kingdom.