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FDAnews Device Daily Bulletin
Aug. 31, 2012 | Vol. 9 No. 172
EU Device Directive Recast to Revise Notified Bodies Role
Revising the role and transparency of notified bodies in the EU’s medical device approval process could be the centerpiece of the European Commission’s recast of the medical device directives (MDD). The upcoming revisions, expected by September, will significantly strengthen the designation and functioning of notified bodies, commission spokesman Frédéric Vincent said. For instance, provisions will be added to ensure that all notified bodies act under the same standards and in a transparent manner. The MDD update comes as some of the EU’s 78 notified bodies are being criticized for lax standards and for allowing manufacturers to shop around for the path of least resistance to bring a device to market.
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