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. they can then be marketed throughout europe. for 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 twenty eighth and twenty second 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. 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. all i really want is for someone to admit that they made a mistake this video but that won't happen because people never do that they've been taught. as andreas wrote it recovered from back surgery. doctors at the clinic in lair 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 two thousand and fourteen 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 like a mesh implant 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 ninety 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. spec but 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 ninety nine point nine. but says it's not as. if there is. no what's yours. one of the. tu v austria now says that in this case important documents were not submitted. 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 of the centuries approach and approach unity to make sure the bronson's was approved in a timely manner to manage them really before production the medical device industry in europe you know provides an overhaul. of new devices that are designed to. help provide solutions truer 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 device in his freezer is most of foremost conclusion providing obviously you should or should be s