White Paper

Assessing the Impact of the Medical Device Regulation (MDR) On Biocompatibility Testing

Since January 1995, medical devices to be marketed in the European Union (EU) have been required to comply with EU Medical Devices Directive (MDD), which specified requirements for safety assessment issues. The initial purpose of the directive was to promote a single European market for trade in medical devices, while ensuring that users and patients were not exposed to unnecessary risks. In 2008, due to several high-profile medical device scandals, and increasing public concern to strengthen the existing regulatory system, an effort was made to overhaul the medical device directive. As such, in 2017, the Medical Device Regulation directive was published to address such issues (MDR 2017/745), and reinforce the confidence in the EU medical device regulation system...

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