Medical device makers face new obstacles to European approval
July 30, 2014 by Arezu Sarvestani
Medical device makers face new obstacles to European approval
Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.
The European Commission’s new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval.
European regulators issue guidance on nanotechnology in medical devices
By Stewart Eisenhart, Emergo Group
The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devices.
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Scotland curbs use of transvaginal mesh amid global outcry
Scottish health regulators are looking to curb use of transvaginal mesh products while independent investigators look into claims that the medical implants hurt women.
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European Commission tables review of Zimmer’s $13B acquisition of Biomet
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EU launches investigation into pelvic mesh
The European Commission asked a scientific advisory panel to look into the safety of surgical procedures to treat urogynecological conditions using mesh products, which have embroiled their makers in tens of thousands of product liability lawsuits in the U.S.
The EU’s executive body asked its Scientific Committee on Emerging and Newly Identified Health Risks for an opinion on the "safety of surgical meshes used in urogynecological surgery," according to the commission’s request.
American Medical Systems lands CE Mark for transvaginal sling
Avedro wins CE Mark for its KXL II system
Waltham,Mass.-based Avedro said it won CE Mark clearance in the European Union for its KXL II cross-linking system.
The technology uses a photorefractive intrastromal cross-linking procedure for non-surgical correction of myopia as well to improve cataract surgery outcomes, according to a company statement.
