EU says “No” to a proposed FDA-like pre-market approval process
The European Parliament today votes not to require medical devices to undergo an approval process akin to that required by the FDA’s pre-market approval program.
The European Parliament today failed to back an EU panel’s recommendation to enact strict requirements for medical device approvals that would have matched those required by the FDA’s pre-market approval program.
The EU body voted instead to strengthen the rules by authorizing unannounced inspections and more stringent monitoring of the “notified bodies” that govern medical device regulation there.
The regulations must still be approved by the governments of the individual countries in the EU. That’s not expected to take place until next year at the earliest and more likely in 2015, Reuters reported.
“The Parliament has voted for many improvements that will effectively improve patient safety. We believe that this paves the way for further needed improvements to be discussed with the Council. We congratulate the Parliament in finding more clarity and positive approaches in important areas supporting safety of patients and innovation for patients in what has been a very complex and highly technical dossier. We are looking forward to seeing continued evolution on a future strengthened EU framework for medical devices,” said Serge Bernasconi, CEO of the European medical device trade group Eucomed, in prepared remarks.
Last month a parliamentary panel OK’d more stringent oversight of medical devices in the European Union that would have required clinical trials for implants and other Class III devices across the pond.