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Back door…open door? Or is German high-risk device plan a door slamming shut?

This article was originally published in Clinica

Executive Summary

While the attention of the EU industry has been fixed on how the EU Council will play the controversial elements of the proposed EU Medical Device Regulation (MDR) – the Article 44 scrutiny clause above all else – tougher market access rules for high-risk medical devices might enter into force via another route, the payer route.

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