t u v self t u v rhineland and. these facilities award c e certifications for things like heart pacemakers syringes and artificial hip joints most of the labs do not employ doctors. manufacturers of medical devices can choose the facility they prefer and they pay for the certification process. if a medical device passes the tests and receives the cæsar to cation it can then be marketed throughout europe. the testing labs are sometimes called appointed authorities the largest such facility in britain is b.s.i. . under a us rodent now wishes he'd never taken part in the study. after december 28th and 27 it's a day that i'll never forget i've had a lot of pain in my life but nothing like the pain i have now never got me. would eventually had to undergo emergency surgery to remove the bits of plastic that had broken away from the disintegrating plastic disc. several more operations were required to clean out all of it. or does life has changed significantly for the worse he's sterile now his nerves are damaged and he's physically incapacitated. even trying to move all i really want is for someone to admit that they made a mistake but that won't happen because people never do that they've been feeling much. as andreas wrote a recovered from back surgery. doctors at the clinic in lear continued to use the plastic discs. the federal government kept getting reports about serious problems with the devices but for years took no action to stop sales. germany's regulatory system has failed patients like thomas waskow. the clinic in layer declined comment for this report to. the clinics head physician has now been fired in connection with illegal payments made by the manufacturer. the british manufacturer has now filed for bankruptcy the former managing director told us that the devices did comply with all government regulations but he declined to comment on problems with the animal tests. in 2014 this dutch journalist showed how easy it is to get approval for a medical device in europe. we're designing a device that's not safe at all in plant that helps to stabilize the uterus we found all the component parts at the supermarket and took some photos of now it's ready to go. and back. similar products are already on the market so the journalists didn't even need to sign up for clinical trials that use human test subject. an estimated 90 percent of such high risk medical devices don't have to go through clinical trials either. and if it is funky the journalists made an appointment at a c.e. test center in vienna and they filmed the meeting with a hidden camera to the. bank often come to work in vain the official doesn't want to see the product itself he'll just rely on the documentation provided by the journalists. or no doctors took part in the process. because. we will agree with 99.9. but says it's not. it's there is there are road know what's yours. why the. tu v austria now says that in this case important documents were not submitted to a. medical device manufacturers from all over the world have set up offices in europe because the approval process is comparatively simple and cheap. approach which is the centuries of poor and the fortunate to make sure the good bronson's as approved in a timely manner to manage them really before british and the medical device industry in europe are provided with over a. 1000000 new devices that are designed to. help one provide solution true or to patients. that may well be the case but again and again there are problems in europe with faulty devices. hip replacement implants that fall apart. breast implants that rupture. and heart pacemakers that don't work properly tens of thousands of these devices have had to be replaced . shouldn't they be tested much more carefully because before they come to market the medical diversion is through the centers most of foremost conclusion providing obviously you're