March 24, 2014 by Arezu Sarvestani
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.
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.
Biotronik announced today that it won CE Mark approval in the European Union for its PK Papyrus coronary stent system.
The Papyrus device is approved for treating acute coronary artery perforation, and features an innovative “electrospun” membrane to increase flexibility by 58% over its competitors, according to a Biotronik company statement.
Reverse Medical Corp. said it won CE Mark approval in the European Union and 510(k) clearance from the FDA for its ReVerse neurovascular microcatheter device.
The regulatory nods are for use in the neurological, peripheral and coronary vasculature for the infusion of diagnostic and therapeutic agents, according to a press release.
By Stewart Eisenhart, Emergo Group
The European Commission has published an unofficial version of its new regulatory requirements for Notified Bodies that play a key role in CE Mark certification for medical devices.
Although the published requirements contain no reference numbers or dates, the document likely provides a clear indication of how Notified Bodies will have to comply.
MASSDEVICE ON CALL — Under fire for being too lenient with medical device approvals, European regulators proposed an update to current CE Mark review and approval practices.
Specifically, the European Commission’s proposed changes address the relative ease with which companies can secure CE Mark approval by "shopping" for an agency in a specific country that will most quickly green-light a new device.
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.