Daily Buzz

Conversation starters for the medtech community

Faulty Implants: Commission, Eucomed Respond

Posted in Implantable devices by Norbert Sparrow on October 25, 2012

The European Commission and pan-European industry association Eucomed have responded to an investigative piece published by the Telegraph that exposed a pair of Notified Bodies who were apparently ready to help a company bring to market a hip implant modelled after a metal-on-metal device banned in the United Kingdom.

The European Commission told the Telegraph that it "recognises that there are some weaknesses in the current regulatory framework, and of course anything which jeopardises patients’ health or safety is unacceptable.” The Commission also noted that the new medical device regulations currently in Parliament include several measures that tighten regulatory oversight on high-risk devices, including hip implants, and subject Notified Bodies to increased oversight. The regulations are not expected to become law until mid-2014 at the earliest.

Noting that it is aware of the investigative report by the Telegraph conducted in association with the British Medical Journal, Eucomed issued the following statement:

"This illustrates Eucomed’s belief that Member States should accelerate the already identified improvements of Notified Bodies foreseen in the Immediate Action Plan of former Commissioner Dalli. In addition, Eucomed fully supports the measures concerning Notified Bodies in the European Commission proposal for a revision of the medical devices regulatory framework."

In the sting, reporters acting as representatives of a fake Chinese company wanting to introduce a metal-on-metal hip implant in the European market submitted a formal application to Notified Bodies in Slovakia and the Czech Republic. The Slovakian organisation was prepared to offer provisional approval for the design, while the body in the Czech Republic was considering licensing the product, reported the newspaper. The hip implant was designed with specifications similar to the Depuy ASR XL Acetabular System, which was recalled in 2010. Read more about this in "Faulty Medical Devices Back in News."

Login or register to post comments

Should the European union

Should the European union take more steps to ensure a healthy Europe? Should it intervene in the European citizens? Do they have to obey these rules?

The science of implants is

The science of implants is going forward in any aspect, However we should see more developments coming in the next years, as the smart phone approach the market.
Getting Rid of constaipation

Sorry, but I lost all trust

Sorry, but I lost all trust in the European Union. What are they doing? why dont they added other countries like Russia into the union? And the commission is doing huge amount of mistakes.
Constipation remedies

The European Commission are

The European Commission are not responsive to the new trends in the world today. There are new families, new tradition in the world. They have to adjust!
constipation 101

Hi there, I found your

Hi there, I found your website via Google whilst looking for a comparable matter, your web site came up, it seems to be good. I’ve bookmarked it in my google bookmarks........

Awesome work, just simply

Awesome work, just simply awesome! Your posts are the best I've ever seen in my life. Your post exhibit passion and excitement. And I appreciate you for that!.....

I am really impressed from

I am really impressed from your immaginative thinking and impressive stated information, i am glad.......

I’m so happy to read this

I’m so happy to read this article. The new medical device regulations currently in Parliament include several measures that tighten regulatory oversight on high-risk devices, including hip implants. Thank you so much for sharing this informative article! Keep updating!!!
outlook 2010 problems

God Animals is a very special

God Animals is a very special many types of old souls which use a vital purpose within the specific incarnation. All knowing animals that always come for one major golfing lessons, cause and event.
writing essays for money

You most likely know some

You most likely know some great routines for getting a ton of activity to your site(s), however as I would like to think, buzz showcasing ranks at the top, and the best part - its Free! Assuming that you aren't utilizing buzz promoting, you are passing up a major opportunity for a torrential slide of connections, swarms of activity, and yes - even acclaim and fortune! What is Buzz promoting?best undergraduate law schools

Thank you for such an amazing

Thank you for such an amazing post …..thanks for your unique thought and also thanks for sharing it with everybody. I enjoy reading post that can make people think…..i want to request you to please write some more blog post on this..remarkable!!!

I was pleased to find this

I was pleased to find this information , I want you to thank for your time of this wonderful read!!! I definitely enjoy every little bit of it and I have you bookmarked to check out new stuff of your blog a must read blog!!!!
manifold valves

Why do we have to wait so

Why do we have to wait so long for a law that will protect the patients? They should have worked on it long ago, the minute the first implant had proved to be faulty. If I was one of the patients who had to suffer because of the implant I would contact Candice Apple and have my rights defended, they can't do everything they want for the sake of profits.

Implants is really very

Implants is really very important in the medical field. However, it will take a long time before everyone can perform such thing in new machines. - Rabbi Binyomin Lisbon