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EU medtech regulatory reform could involve unannounced notified body visits, greater transparency and tighter controls on Class III devices

This article was originally published in SRA

Executive Summary

Among the proposals the European Commission is considering under the planned revision of the regulatory framework for medical devices in the EU are unannounced visits to manufacturers by notified bodies and the public having access to crucial notified body information. A pre-release version of proposed legislation that would update the Medical Devices Directive indicates that the commission has resisted pressure to introduce premarket approval for high-risk innovative devices, but that it supports the introduction of different, tighter procedures for this high-risk category.

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