Document Transition Periods

Industry Perspective on the Implementation Status of the MDR/IVDR

In less than 1 year the new Medical Device Regulation will enter into full effect. Soon after, so too will the In Vitro Diagnostic Medical Device Regulation.

The Medical Device Industry in Europe is deeply concerned that the new regulatory system will not be ready on time. If the system is not ready well ahead of the deadline of May 2020, it puts at risk the continued supply of life-saving and life-enhancing technologies.

European Commission and Member States need to move faster in order to get the new system ready on time. We must not put patients at risk, nor negatively impact healthcare systems.

We recognize the shift to a new system is a major task. This presentation seeks to clearly lay out the fundamental areas that need addressing with urgency.

Posted on 14.06.2019

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