Daily Buzz

Conversation starters for the medtech community

Faulty Medical Devices Back in News


Posted in Orthopedics by Norbert Sparrow on October 23, 2012

As the European Commission's proposed measures for new medical device regulations go through the European Parliament, a sting operation engineered by the Telegraph and British Medical Journal has put the spotlight on "unscrupulous EU regulators" and "loopholes in the woeful EU system to approve devices." The undercover investigation involved submitting a formal application to Notified Bodies in Slovakia and the Czech Republic for a hip implant modelled after a metal-on-metal device banned in the United Kingdom. The Slovakian organisation was prepared to offer provisional approval for the design, while the body in the Czech Republic was considering licensing the product, reports the newspaper.

The hip implant was designed by medical experts for the purposes of the investigation, writes the Telegraph, with specifications similar to the Depuy ASR XL Acetabular System, which was recalled in 2010. Reporters submitting the technical dossier posed as representatives of a Chinese company seeking to market the implant on the EU market. A representative of the Slovakian NB reportedly told them that the organisation could not give "exact advice" but would just "cross the line and say just do this and it will be OK. Therefore we have so high rate of successful certification [sic]." A representative of the Czech NB is said to have told reporters that it would not put obstacles in the way and that it was "on the side of the manufacturer . . . not the patient."

Metal-on-metal implants have been shown to produce microscopic metal debris that can lead to soft tissue and bone damage around the hip joint, sometimes requiring revision surgery. In March 2012, British experts at the world's biggest artificial joint registry said doctors should stop using metal-on-metal hip replacements.

Commenting to EMDT on the sting operation, medico-legal specialist Erik Vollebregt says, "this is exactly what the European Commission asked the member states to look at a year ago in [former Commissioner of Health] Dalli's action plan. To me this is proof that the Commission's planned shake-out of bad NBs is necessary (the good NBs are also convinced of this), but that the member states must play their role and take responsibility and monitor the NBs they accreditate much more closely."

The new medical device regulations that are now going through Parliament include stricter control of Notified Bodies and a number of other measures that tighten regulatory requirements, notably a much-debated scrutiny procedure that much of industry opposes. Some of those measures were introduced to assuage public concerns arising from the Pip implant scandal that erupted earlier this year.

What impact will this new scandal have on the regulation? Tell us what you think.




Login or register to post comments

This is a truly good site

This is a truly good site post. Not too many people would actually, the way you just did. I am really impressed that there is so much information about this subject that have been uncovered and you’ve done your best, with so much class. If wanted to know more about green smoke reviews, than by all means come in and check our stuff.
mobile app

I am happy to find this post

I am happy to find this post very useful for me, as it contains lot of information. I always prefer to read the quality content and this thing I found in you post. Thanks for sharing.
productos limpieza

now going through Parliament

now going through Parliament include stricter control of Notified Bodies and a number of other measures that tighten.. idaho falls carpet cleaning

Very useful post. This is my

Very useful post. This is my first time i visit here. I found so many interesting stuff in your blog especially its discussion. Really its great article. Keep it up.
phen375 customer reviews

I really appreciate the kind

I really appreciate the kind of topics you post here. Thanks for sharing us a great information that is actually helpful. Good day!Top mac and pc data

I’ve read some good stuff

I’ve read some good stuff here. Definitely worth bookmarking for revisiting. I surprise how much effort you put to create such a great informative website.
ultrasound technician 2015

I’ve been surfing online more

I’ve been surfing online more than three hours today, yet I never found any interesting article like yours. It’s pretty worth enough for me. In my opinion, if all webmasters and bloggers made good content as you did, the web will be a lot more useful than ever before.
http://www.ceag-ag.com/

Impressive web site,

Impressive web site, Distinguished feedback that I can tackle. Im moving forward and may apply to my current job as a pet sitter, which is very enjoyable, but I need to additional expand. Regards.
auto binary signals reviews

I like this post,And I guess

I like this post,And I guess that they having fun to read this post,they shall take a good site to make a information,thanks for sharing it to me.
site

Excellent .. Amazing .. I’ll

Excellent .. Amazing .. I’ll bookmark your blog and take the feeds also…I’m happy to find so many useful info here in the post, we need work out more techniques in this regard, thanks for sharing.
https://rebelmouse.com/ultimateherpesprotocolreviews

A very awesome blog post. We

A very awesome blog post. We are really grateful for your blog post. You will find a lot of approaches after visiting your post. I was exactly searching for. Thanks for such post and please keep it up. Great work.
american home warranty
home warranty

I am just pretty happy to

I am just pretty happy to sign up ones own guestbook these days,Your own feedback and listed below are excellent in my opinion,incidentally I should say also definitely will teach some great supplements for your needs every.
home warranty reviews
hms home warranty

Commission's planned

Commission's planned shake-out of bad NBs is necessary (the good NBs are also convinced of this), but that the member states must play their role and take responsibility and monitor the NBs they accreditate much more closely.
about

Positive site, where did u

Positive site, where did u come up with the information on this posting? I'm pleased I discovered it though, ill be checking back soon to find out what additional posts you include.
Turbulence Training Reviews 2015

Kami toko onlien menjual

Kami toko onlien menjual produk Mebel Jepara Minimalis yang menawarkan produk produk mebel asli jepara memang sudah dikenal hingga mancanegara, jepara selalu menjaga kualitas produk furniture dengan sangat teliti Toko Mebel Online Mulai dengan produk produk minimalis yang sqangat elegant hingga produk klasik modern yang sekarang sedang trend di beberapa tahun terakhir, produk klasik modern kami meliputi Kursi Tamu Jati Jepara dengan model klasik modern juga tersedia mebel minimalis khas mebel jepara yang di buat dengan menggunakan material kayu perhutani pilihan, kayu perhutani dipilih karena memang kualitasnya yang jauh dari kayu kebun, produk Mebel Jepara dengan model simple elagant kami tawarkan dengan harga yang cukup kompetitif, semuanya tergantung akan banyaknya bahan yang digunakan juga tingkat kerumitan produk dengan Furniture Jepara yang tentunya tidak mengurangi kualitas dari produk Mebel Jepara Minimalis yang kami tawarkan. Kami selalu berupaya dengan menawarkan produk produk Furniture Jati Jepara dengan desain terbaru, dikarenakan setiap produk kami mempunyai keistimewaan tersendiri yang berbeda dengan produk mebel lainnya, yaitu tingkat kualitas kehalusan finishing juga kuaslitas ukiran yang khas Mebel Jepara Minimalis kami selalu terjaga kualitas dan pamornya. Kami juga mempunyai banyak produk galleri yang dapat anda jadikan patokan untuk anda tempatkan di ruang tamu rumah anda, produk produk tersebuat dapat anda lihat disini Kursi Tamu Jati Minimalis asli produk Cv. Karya Priboemi Jepara yang dapat anda pesan secara custom atau biasa disebut pesanan sesuai keinginan anda, itu semua kami produksi menggunakan material kayu mahoni perhutani dan kayu Mebel Jepara Minimalis dengan label Cv. Karya Priboemi Jepara yang sudah dikenal baik dalam maupun luar negri, anda tidak perlu khawatir akan kualitas dari setiap produk kami, beragam model Kursi Tamu Minimalis Modern kami sudah mulai membuka pemesanan dengan anda cukup dengan santai diruamh, anda tinggal menyodorkan bagaimana produk mebel yang anda inginkan, anda dp maka kami akan kerjakan, untuk lama proses tergantung tingkat kerumitan produk pesanan, itu smua bisasa kami tawarkan secara Mebel Jepara Murah dengan kekuatan kontruksi pengrajin mebel jepara asli, yang memang sudah profesional dalam proses pembuatan kontruksi, pengrajin profesional iru semua ada di perusahaan kami Cv. Karya Priboemi Jepara, kontruksi tersebuat bisa anda pakai hingga puluhan tahun, karena kualitas kami di atas produk produk lain, yang banyak di jual di pasaran Furniture Jepara tentunya sangat kokoh. Kam ndart export, pamor produk mebel dari jepara memang masih banyak dikagumi oleh masyarakat luas, dikarenakan tenaga tenaga mebel jepara mempunyai pengalaman yang lebih baik ketimbang tenaga mebel di luar sana, bahkan produk seperti Meja Makan Minimalis Modern sangat laris di pasaran baik itu dalam pasar lokal maupun interlokal, banyak sekali yang berbondong bondong ke jepara hanya untuk membeli produk produk tersebut Mebel Jati Jepara dsekarang sudah banyak di copy, salah satunya negri china, malaysia yang merekrut tenaga di jepara untuk mengajarkan kepada warganya di sana. dan anda juga dapat memilih warna di menu dan tak ketinggalan kami juga menawarnak produk Kamar Set Jati Minimalis menjadi brand ambrossador di beberapa tahun terakhgir, maraknya rumah berdesain minimalis modern membuat produk ini sangat laku di pasaran, untuk katalognya anda dapat  melihat katalog produknya disini Kamar Set Mewah juga bisa disini untuk katalog produk ruang tamu dengan desain minimalis, anda bisa mengirimkan gambar desain yang anda inginkan, atau anda juga bisa lihat katalog kami disini Kursi Tamu Klasik Klasik Eropa kota kami sangat terkenal dengan produk produk etnik khas dari jawa yang terbuat dengan menggunakan material kayu jati yang di ukir dengan ukiran khas mebel jepara yang membuatnya begitu mendunia hingga sekarang, anda pasti akan tercengan jika sudah melihat produk yang satu ini Pintu Gebyok Jepara meja makan dengan desain klasik minimalis semuanya ada di jepara, kami selaku salah satu perusahaan Mebel Jepara Minimalis di jepara selalu berupaya membuat desain baru agar bisa tetap bersaing, salah satu produk hasil desain kami adalah sebagai berikut Meja Makan Minimalis Modern kota jepara juga terkenal dengan produsen tempat tidur yang cantik elok dan elegant yang tentunya produk itu sendiri diproses dengan sangat terkontrol, untuk katalog produknya anda bisa langsung tengok disini Tempat Tidur Minimalis untuk katalog produk dengan desain klasik ataupun minimalis seperti meja makan ataupun yang lainnya anda juga bisa memilihnya di kolom produk dengan menu kategory Meja Makan Minimalis Modern produk produk kami tentunya mempunyai nilai tersendiri yang tentunya berkualitas tinggi, karena kami proses dengan melalui kontol yang sangat teliti. Seperti produk produk kursi tamu misalnya, untuk membuat Kursi Tamu Minimalis Murah kami memakai bahan dengan kualitas grade A jadi anda tidak perlu ragu lagi akan kualitas dari produk produk mebel yang kami tawarkan kepada anda. Ada lagi produk yang tak kalah larisnya yang ada di jepara yaitu Tempat Tidur Minimalis Modern , produk ini merupakan produk paling penting yang harus ada dalam suatu hunian rumah. Apapun bentuk / model dari tempat tidur tersebut, yang terpenting adalah kita nyaman saat beristirahat tentunya. Selain menjual tempat tidur dalam satuan, kami juga menerima pemesanan produk untuk ruang kamar berupa set kamar tidur. Kamar Set Minimalis Modern itu sendiri nantinya akan terdiri dari tempat tidur lemari pakaian dua nakas dan meja rias, anda juga bisa memesannya terpisah Mebel Jepara selalu menjadi daya tarik tersendiri untuk turis asing yang ingin membuat usaha furniture, banyak sekali turis asling berbondong bondong ke jepara untuk memulai bisnisnya, tidak hanya itu banyak juga turis asing yang ingin mengisi rumahnya dengan membeli produk produk seperti tempat tidur kursi tamu meja makan yang asli dan khas Mebel Jepara kami juga menyediakan produk lain yang tak kalah pamornya di beberapa tahun terakhir, produk ini tentunya memiliki ciri khas tersendiri. Pada produk ini kayu jati kami olah sedemikian hingga menjadi produk Meja Makan Jati Jepara yang mewah dengan keaslian aksen ukiran khas mebel jepara jual mebel jati harga murah asli mebel jepara, kami menawarkan harga standart furniture jepara dengan kualitas yang tentunya terbaik Penerapan ruang yang akan anda isi mebel harus anda perhatikan terlebih dahulu sebelum membelinya, dalam hal ini saya ada rekomendasi untuk anda untuk berkonsultasi terlebih dahulu dengan pakarnya, anda bisa langsung menuju untuk saat ini mebel jepara memang sudah sangat berkembang, jepara terkenal hingga ke mancanegara sebagai pusat industri mebel terbesar di dunia, produk produknya sudah banyak yang di export ke mancanegara, salah satunya italy Toko Mebel Jepara Kami menyediakan layanan online untuk pemesanan Mebel Jepara Minimalis dengan sistem online.
Toko Mebel Mebel Jati jual mebel jati harga murah asli mebel jepara, kami menawarkan harga standart furniture jepara dengan kualitas yang tentunya terbaik Toko Mebel Jepara berkualitas asli produk mebel jepara yang dibuat oleh tangan tangan ahli pengrajin mebel jepara yang ada di perusahaan kami Mebel Jepara Online mulai dari meja makan jati, tempat tidur minimalis, meja makan jati, kursi tamu murah, kamar set minimalis semuanya tersedia termasuk gapura pintu gebyok jati, juga Kursi Tamu Jati Jepara banyak sekali kami menawarkan produk mebel jati yang kami gunakan sebagai bahan baku, juga tersedia bahan kayu mahoni untuk mebel dengan pewarnaan cat duco Meja Makan Jati hasil karya Cv. Karya Priboemi Jepara yang sudah dikenal hingga mancanegara salah satunya adalah pintu gebyok. produk ini sangat tenar dan etnik jawanya masih melekat pada produk Mebel Jepara Minimalis Ada juga produk unggulan lain seperti tempat tidur, meja makan, set meja makan dan banyak lainnya.
Oleh karena itu mulai dari lima tahun terakhir kami sudah mengembangkan untuk pembelian produk furniture dengan menawarkannya di Mebel Jepara Online Ada juga produk unggulan lain seperti tempat tidur, meja makan, set meja makan dan banyak lainnya.
Oleh karena itu mulai dari lima tahun terakhir kami sudah mengembangkan untuk pembelian produk furniture dengan menawarkannya di Mebel Minimalis Jati

Great Southern Coins is the

Great Southern Coins is the premiere silver maple leaf coins dealer. Shop with confidence and assurance that all silver and gold coins are backed with a US guarantee shipped direct to your door quickly. Visit them online to add to your collection or start one today. home warranty arizona reviews
home warranty bpg

Very interesting blog. Alot

Very interesting blog. Alot of blogs I see these days don't really provide anything that I'm interested in, but I'm most definately interested in this one. Just thought that I would post and let you know.
https://www.rebelmouse.com/textyourexback/

Love what you're doing here

Love what you're doing here guys, keep it up!..
scentsy light bulb

It was great to see the old

It was great to see the old printshop and everyone who works there again. I am excited to see a printing business still operating and growing, great job guys

Reporters submitting the

Reporters submitting the technical dossier posed as representatives of a Chinese company seeking to market the implant on the EU market.
healthwolf.com/beauty-fashion/micro-loop-hair-extensions/

Such a very useful article.

Such a very useful article. Very interesting to read this article.I would like to thank you for the efforts you had made for writing this awesome article. home warranty of america
american home warranty

This is a wonderful article,

This is a wonderful article, Given so much info in it, These type of articles keeps the users interest in the website, and keep on sharing more ... good luck. first american home warranty login
first american home warranty

Reporters submitting the

Reporters submitting the technical dossier posed as representatives of a Chinese company seeking to market the implant on the EU market.
agen sbobet terbaik

I just couldn't leave your

I just couldn't leave your website before telling you that I truly enjoyed the top quality info you present to your visitors? Will be back again frequently to check up on new posts.
megashare info think like a man

The new medical device

The new medical device regulations that are now going through Parliament include stricter control of Notified Bodies and a number of other measures that tighten regulatory requirements
electricien evry

Yes i am totally agreed with

Yes i am totally agreed with this article and i just want say that this article is very nice and very informative article.I will make sure to be reading your blog more. You made a good point but I can't help but wonder, what about the other side? !!!!!!THANKS!!!!!!
Solarmodule

Thanks for posting this info.

Thanks for posting this info. I just want to let you know that I just check out your site and I find it very interesting and informative. I can't wait to read lots of your posts.
adesivos de unhas

A representative of the Czech

A representative of the Czech NB is said to have told reporters that it would not put obstacles in the way and that it was "on the side of the manufacturer
Buy Facebook likes

The hip implant was designed

The hip implant was designed by medical experts for the purposes of the investigation, writes the Telegraph, with specifications similar to the Depuy ASR XL Acetabular System, which was recalled in 2010.
Buy Instagram followers

A representative of the

A representative of the Slovakian NB reportedly told them that the organisation could not give "exact advice" but would just "cross the line and say just do this and it will be OK.
http://www.topinstagramfollowers.com/

Some of those measures were

Some of those measures were introduced to assuage public concerns arising from the Pip implant scandal that erupted earlier this year.
coffee sofa

I would like to thank you for

I would like to thank you for the efforts you have made in writing this article. I am hoping the same best work from you in the future as well..
herpes protocol melanie addington

This is such a great resource

This is such a great resource that you are providing and you give it away for free. I love seeing websites that understand the value of providing a quality resource for free. It is the old what goes around comes around routine.
plumbing contractor

Your content is valid and

Your content is valid and informative in my personal opinion. You have really done a lot of research on this topic. Thanks for sharing it.
hot pressing tech

The hip implant was designed

The hip implant was designed by medical experts for the purposes of the investigation, writes the Telegraph, with specifications similar to the Depuy ASR XL Acetabular System
continued

A representative of the Czech

A representative of the Czech NB is said to have told reporters that it would not put obstacles in the way and that it was "on the side of the manufacturer

Health Tips

which was recalled in 2010.

which was recalled in 2010. Reporters submitting the technical dossier posed as representatives of a Chinese company seeking to market the implant on the EU market.

pikalainaa 2014

Pretty good post. I just

Pretty good post. I just stumbled upon your blog and wanted to say that I have really enjoyed reading your blog posts. Any way I’ll be subscribing to your feed and I hope you post again soon.
auto and homeowners insurance

this is exactly what the

this is exactly what the European Commission asked the member states to look at a year ago in [former Commissioner of Health] Dalli's action plan.
https://plus.google.com/100704690420902897941/posts

useful information on topics

useful information on topics that plenty are interested on for this wonderful post.Admiring the time and effort you put into your b!..
taxi hochgurgl

I read a article under the

I read a article under the same title some time ago, but this articles quality is much, much better. How you do this..
watch movies online free full movie download

Your blog provided us with

Your blog provided us with valuable information to work with. Each & every tips of your post are awesome. Thanks a lot for sharing. Keep blogging,
judi sbobet

I think this is an

I think this is an informative post and it is very useful and knowledgeable. therefore, I would like to thank you for the efforts you have made in writing this article.
judi sbobet

This is very educational

This is very educational content and written well for a change. It's nice to see that some people still understand how to write a quality post!
hotel discount code

I love the way you write and

I love the way you write and share your niche! Very interesting and different! Keep it coming!
rusty moore visual impact muscle building pdf reviews

A representative of the Czech

A representative of the Czech NB is said to have told reporters that it would not put obstacles in the way and that it was "on the side of the manufacturer . . . not the patient.
serrurier paris

The new medical device

The new medical device regulations that are now going through Parliament include stricter control of Notified Bodies and a number of other measures that tighten regulatory requirements
serrurier paris

Great Article it its really

Great Article it its really informative and innovative keep us posted with new updates. its was really valuable. thanks a lot. tapijt

A representative of the Czech

A representative of the Czech NB is said to have told reporters that it would not put obstacles in the way and that it was "on the side of the manufacturer . . . not the patient."
http://www.wyndhammannheim.com/

"this is exactly what the

"this is exactly what the European Commission asked the member states to look at a year ago in [former Commissioner of Health] Dalli's action plan.
reservation