E.U. scrutinizes medtech review "shopping"
European Healthcare regulators take a hard look at CE Mark loopholes that allow medical device companies to “shop” for easier pathways to approval.
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.