E.U. scrutinizes medtech review "shopping" | MassDevice.com On Call

July 3, 2013 by Sony Salzman

European Healthcare regulators take a hard look at CE Mark loopholes that allow medical device companies to “shop” for easier pathways to approval.

MassDevice On Call

MASSDEVICE ON CALL — Under fire for being too lenient with medical device approvals, European regulators proposed an update to current CE Mark review and approval practices.

Specifically, the European Commission's proposed changes address the relative ease with which companies can secure CE Mark approval by "shopping" for an agency in a specific country that will most quickly green-light a new device.

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The new proposal would scrutinize private companies that currently help guide approvals, homogenize the approval process among countries and increase pre-market information transparency between countries, according to QMed.

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