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.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of or its employees.

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