The European Medical Device Regulation (EU MDR) is one of the most impactful pieces of legislation to hit the industry in decades. It was established to ensure a robust, transparent, predictable and sustainable regulatory framework for medical devices in the EU, improving health and patient safety, while supporting innovation. And among the many changes affecting medical device manufacturers is labeling and labeling translation. Before, language requirements were left to the member states.
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.
In PART II of a two-part webinar series, guest presenter, Yvonne Middlefell, RAC, will continue discussions about the MDR and review the new EU regulation for medical devices and implications for localization. She will share insights on the anticipated need for more translations and localization work, technical documentation and the increased transparency that the European Database for Medical Devices (EUDAMED) will introduce. She will also offer recommendations on how medical device companies should plan to meet the new requirements and aim to minimize risk.
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MEET THE SPEAKER
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.