Watch now: Regulation (EU) 2024/1860 and IVDR compliance in Europe
Our Emergo by UL expert explains what you need to know so that you can gain or maintain EU IVD market access.
Webinar date
Oct. 16, 2024
Speaker
Heather Crawford, Manager, Quality & Regulatory Affairs Program
Are you an IVD medical device manufacturer who needs a better understanding of what action you will need to take and when so that you can make use of the extension under the revised Regulation (EU) 2024/1860?
The European Commission amended the In Vitro Diagnostic Devices Regulation (EU) 2017/746 (IVDR), Article 110. This was done with the adoption of Regulation (EU) 2024/1860. The Regulation (EU) 2024/1860 introduces a staggered extension of the transition period provided for in the IVDR under certain conditions.
About the presenter
Heather Crawford, Manager, Quality & Regulatory Affairs Program
Heather Crawford has over 25 years of experience in the medical device industry, specializing in regulatory affairs and quality management systems. Her background includes developing and contributing to clinical evaluation reports, EU technical documentation, U.S. Pre-market Approval (PMA) applications, and U.S. 510(k) submissions. She also has extensive experience in standards development and contributes to the U.S. position on standards, including ISO 13485 and ISO 9001. She works directly with customers on their regulatory and quality projects. She also peer reviews reports and regulatory filings for her colleagues. Prior to joining Emergo by UL, Heather worked in the healthcare industry, focusing on implantable devices and new products.
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