The Medical Device Business Journal — Medical Device News & Articles | MassDevice
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.
This month the European Commission will release its updated medical device review guidelines, with some lauding a win for regulatory oversight while others lament the inevitable delays for devices vying for market access.
The new proposal aims to fullfil a European Parliament request for more stringent medtech scrutiny by bolstering an existing pre-market review system with additional checks and more transparency.
In an apparent effort to push back against medical device industry lobbying, the FDA crafted an internal report outlining agency successes in keeping "malfunctioning or needlessly invasive high-risk medical devices" off the U.S. market, despite their approval in the European Union.
The gesture may represent a response to FDA critics, who have long called the the agency’s medical device pathways inconsistent, unpredictable and lacking in transparency. The same critics often point to the EU’s less-stringent review system as a model for the U.S.
Health care giant Johnson & Johnson (NYSE:JNJ) submitted concessions to the European Commission reviewing the company’s $21.3 billion buyout of Synthes Inc. in hopes of easing regulator concerns.
The Eurozone regulators extended the deadline for a decision on the proposed merger until April 26, to grant additional time to review the concessions, the details of which were not made public.
MASSDEVICE ON CALL — British medical regulatory Kent Woods warned against reactionary reforms to the European device review process amid growing clamor for overhaul in light of the public health crisis surrounding substandard breast implants.
"The question that arises is whether the broad principle of how we do it in Europe is right or not?" Woods told a press briefing in London. "Are we looking for incremental improvements to a system that is in place, or are we looking for root and branch change?"
European med-tech lobby Eucomed joined forces with regulators in calling for a revised framework for medical device review in light of the ongoing public health crisis surrounding substandard breast implants.
The European Commission called for immediate action to tighten controls and increase surveillance following the discovery of "fraudulent use of non medical grade silicone in breast implants" manufactured by a French device company, Poly Implant Prothese.
