Medtech industry advocacy groups on both sides of the Atlantic are pushing for regulatory cooperation in the Transatlantic Trade and Investment partnership, which is entering its 3rd year of negotiations. The groups, represented by AdvaMed, COCIR, EDMA, Eucomed and MITA, hit on 3 priority areas for medical device regulation cooperation. The combined entities are calling […]
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.
MASSDEVICE ON CALL — European medical device makers are fighting against the swell of support for new laws that would tighten regulatory oversight of healthcare technologies.
Lawmakers and healthcare officials have backed proposed regulation that would create within the E.U. regulatory body an agency similar to the FDA that would require more from new devices looking to sell on local markets.
A European Parliament panel yesterday OK’d more stringent oversight of medical devices in the European Union that would require clinical trials for implants and other Class III devices across the pond.*
If enacted, the new regulations would require implants like heart pumps or joint replacements to undergo a process much more like the FDA’s pre-market approval protocol in the U.S., under the purview of the European Medicines Agency.
New medical device regulation under consideration by the European Union would cost €17.5 billion to implement, according to a member survey by medtech trade group Eucomed.
MASSDEVICE ON CALL — Medical device makers and European regulators appear to be at an impasse over new regulations proposed in the wake of the breast implant recall that revealed shortcoming in the E.U.
The European Parliament is poised to host a public debate today to hash out the details of a new medtech regulatory system that incorporates some elements that are reminiscent of the device oversight in the U.S.
European medical device makers continue to fight back against proposed healthcare regulations that would add a new layer of pre-market review to the medtech approval pathway.
Device lobby Eucomed issued a handful of recommendations in response to the European Commission’s "scrutiny panel" model, which would designate a central FDA-like body to review medical devices after they had already gone through the existing certification process.
As medical device companies digest the European Commission’s newly released medical device regulatory recommendations, MassDevice.com caught up with Serge Bernasconi, CEO of Eucomed and the European Diagnostic Manufacturers Assn. (EDMA), to discuss how the creation of a central FDA-like body to oversee pre-market medtech review for the European Union might impact the broader device industry.
Medical device groups were quick to criticize the European Commission’s newly released medical device regulatory guidelines, saying certain updates stall innovation rather than bolster safety.
European medical device lobbying group welcomed most of the proposed measures, but took exception to the so-called "scrutiny procedure," through with a central panel of advisors would monitor the various assessment agencies that currently oversee medical device control in the European Union.
MASSDEVICE ON CALL — A clutch of European medical device makers lamented the European Parliament’s vote in favor of a new pre-market authorization system for medical devices that the med-tech makers say create "years of delay in the availability of medical technology solutions to European citizens."