The EU’s Medical Device Regulation (MDR) was officially published on 5 May 2017 and came into force on 25 May 2017. The MDR will replace the EU’s current Medical Device Directive (93/42/EEC) and the EU’s Directive on active implantable medical devices (90/385/EEC). Europe’s new Medical Devices Regulation (MDR) will bring significant regulatory changes that may impact multiple business units within your organization.
As companies begin planning their transition program to bring their organizations into compliance under the new Regulation, it’s important to be aware of all the major changes that will require planning and action. Contact us if you seek any help in Awareness and Implementation of EU MDR 2017/745
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