EU Plenary Debates How To Protect Orphan Devices From MDR Crisis

Steps are being taken in the EU to address shortages of critical medical devices as a result of regulatory pressures, including those for use in children and for rare conditions, the European Commission’s Stella Kyriakides stated during a recent debate.

EU Parliament
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The European Commission has established a taskforce for orphan medical devices following industry warnings that essential medtech produced used for patients with rare conditions, or in children, may vanish from the EU market due to the crisis created by the new Medical Device Regulation (MDR).

There have been calls for an extension to the transition period from the former medical devices directive to the new MDR, which is set to end in May 2024. For...

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