EU MDR Conformity Assessment Options for Medical Devices: Determining the proper path to CE marking for your products
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Aimed at protecting public health and patient safety with a more modernized and robust legislative framework within the EU, the 2017 Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) have driven significant changes across medical device manufacturing in the last few years.
Adapting to these new regulations has meant meeting higher standards for classification, conformity assessments and compliance with general safety and performance requirements (GSPRs) for CE marking.
Learn more about the opportunities and challenges of MDR and IVDR compliance with our subject matter expert, Rachel Paul-Zieger, in her latest whitepaper.
About the author
Rachel Paul-Zieger
Senior consultant, quality and regulatory affairs
Rachel has over 13 years of experience in the medical device industry as well as international experience in high-risk device regulatory submissions and quality assurance requirements.
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