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The Role Of The Contract Manufacturer Under The EU MDR & IVDR By Mark Durivage, Quality Systems Compliance LLC Regulation (EU) 2017/745 Medical Device (EU MDR) of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002, and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC Active Implantable Medical Devices Directive (EU AIMDD) and 93/42/EEC Medical Device Directive (EU MDD) was set for enforcement in May 2020. However, due to the global COVID-19 pandemic, the European Commission extended the date of application for EU MDR by 12 months, meaning medical device companies now have until May 26, 2021 to comply with MDR requirements. ....
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