Euro device makers cry 'nay' on FDA-like proposal for medtech review
September 26, 2012 by MassDevice staff
Medical device makers warn against new guidelines that would establish a central FDA-like body to oversee pre-market medtech review for the European Union.
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.
- Show paged
- Login to post comments
-
Permalink
RECENT BLOG POSTS
- Mobilizing on the back end of a disaster
- Rising healthcare costs not directly tied to medical technology, according to study
- CareFusion may be weighing 2 very different deals
- Medical Devices: What does it really mean to be disruptive?
- Smarter strategic moves bode well for Wright Medical
- The IRS, NSA, and Justice Department scandals and what they mean for HIPAA
- A Father's Day remembrance
- What I'd tell the graduating medical school class of 2013
- Silencing immune attacks in type 1 diabetes
- Eucomed guidance clarifies RoHS compliance for medical device companies
Navigation
NEWS
Medical device tax: Consultant calls offshoring concerns 'horse hockey'
Concerns that the medical device tax will push companies to lay off workers and move operations...
FDA clears OrthoSensor's Verasense knee replacement device
The FDA clears OrthoSensor's Verasense device, designed to help surgeons fit knee replacement...
ArtVentive Medical wins CE Mark for peripheral catheter
ArtVentive Medical Group wins CE Mark approval in the European Union for its EOS peripheral vascular...
Recalls: FDA makes Endologix catheter introducer recall Class I
The FDA hits Endologix's catheter introducer device recall with Class I status, its most serious...
pSivida gains big on buyout rumor
A blogger's speculation that pSivida might be in line for a buyout bid sends the ophthalmology...
