European medical device and IVD regulations officially published


emergo-1x1By Stewart Eisenhart, Emergo Group

The European Commission has officially published the Medical Device Regulations (MDR) 2017/745 and In Vitro Diagnostic Regulations (IVDR) 2017/746 on May 5, 2017 in the Official Journal of the European Union (OJEU). The MDR will replace the Active Implantable Medical Devices Directive (90/385/EEC — AIMD) and the Medical Devices Directive (93/42/EEC — MDD), while the IVDR will replace the In-Vitro Diagnostic Medical Devices Directive (89/79/EC — IVDD).

Get the full story here at the Emergo Group’s blog.

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