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Eucomed

U.S., EU medical device associations push ‘regulatory cooperation’

February 12, 2016 By Fink Densford

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 […]

Filed Under: Business/Financial News, Regulatory/Compliance Tagged With: AdvaMed, Eucomed, Medical Imaging & Technology Alliance (MITA)

EU Parliament: No PMAs here please

October 22, 2013 By Brad Perriello Leave a Comment

EU Parliament: No PMAs here please

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.

Filed Under: News Well, Regulatory/Compliance Tagged With: Eucomed, European Parliament, Exports

Device makers fight as E.U. lawmakers back heavier regulation | MassDevice.com On Call

September 30, 2013 By Arezu Sarvestani Leave a Comment

MassDevice On Call

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.

Filed Under: News Well, Regulatory/Compliance Tagged With: Eucomed, On Call

EU panel approves FDA-like requirements for medical devices

September 26, 2013 By Brad Perriello Leave a Comment

EU panel approves FDA-like requirements for medical devices

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.

Filed Under: News Well, Regulatory/Compliance Tagged With: Eucomed, European Union, Exports

Survey: New EU medical device regulations would cost €17.5B

September 12, 2013 By Brad Perriello Leave a Comment

Survey: New EU medical device regulations would cost €17.5B

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.

Filed Under: News Well, Regulatory/Compliance Tagged With: Eucomed, Exports

Device makers, regulators butt heads over new E.U. regulations | MassDevice.com On Call

February 26, 2013 By Arezu Sarvestani Leave a Comment

MassDevice On Call

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.

Filed Under: News Well Tagged With: Eucomed, On Call

European medical device makers seek a compromise in new legislation

January 31, 2013 By MassDevice staff Leave a Comment

Eucomed

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.

Filed Under: News Well Tagged With: Eucomed, Lobbying

EU’s new medical device regulations: 5 questions with Eucomed’s Serge Bernasconi

September 27, 2012 By Brian Johnson Leave a Comment

bernasconi

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.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Eucomed

Euro device makers cry ‘nay’ on FDA-like proposal for medtech review

September 26, 2012 By MassDevice staff Leave a Comment

European Commission flag

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.

Filed Under: News Well Tagged With: Eucomed, European Commission

Former Medtronic exec named head of new EU device & Dx alliance | Personnel Moves

July 11, 2012 By MassDevice staff Leave a Comment

fired/hired

 CEO of both Eucomed and EDMA comes from Medtronic

Filed Under: News Well Tagged With: Eucomed, European Diagnostic Manufacturers Assn., Mauna Kea Technologies, Personnel Moves, Rotech Healthcare Inc.

Eurozone med-tech makers lament a new PMA device review process | MassDevice.com On Call

June 18, 2012 By MassDevice staff Leave a Comment

MassDevice On Call

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."

Filed Under: Food & Drug Administration (FDA), News Well, Pre-Market Approval (PMA), Replacement Heart Valves, Stem Cells Tagged With: Eucomed, On Call

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