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Regulatory Affairs, Medical Devices

EU MDR: Assessing the impact on biocompatibility testing


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In 2008, due to several high-profile medical device scandals, and increasing public concern to strengthen the existing regulatory system in the European Union, an effort was made to overhaul the EU Medical Devices Directive (MDD).

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. The EU MDR will replace the current AIMDD (Active Implantable Medical Device Directive) and MDD (Medical Device Directive); and, by May 2020, all medical device manufacturers will need to be compliant.

This whitepaper looks at the changes brought by the EU MDR around the testing of medical device biocompatibility, and what this means in practice for ensuring compliance.

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This piece represents the views of the author and not necessarily the views of Informa Connect Life Sciences or the Biocompatibility for Medical Devices conference.

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