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MDR and IVDR - What Medical Device Manufacturers Need to Know About New EU Standards

Big changes are on the horizon for medical device manufacturers who market and sell their devices in Europe. On May 5, 2017 the European Union (EU) published updated regulations on medical device safety and quality, including the new Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR).

These new regulations represent the first major update to EU medical device standards in more than two decades. What’s more, they’re set to replace all three existing Medical Device Directives (MDD).

So what will the new standards mean for medical device manufacturers? This post looks at some key considerations in terms of timing, quality management practices and clinical requirements.

Rachel Beavins Tracy
By Rachel Beavins Tracy
on Mon, May 28, 2018
   
MDR and IVDR - What Medical Device Manufacturers Need to Know About New EU Standards

Big changes are on the horizon for medical device manufacturers who market and sell their devices in Europe. On May 5, 2017...

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How a Quality Management System Can Ensure Compliance With FDA 21 CFR Part 820

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