The US Food and Drug Administration has asked manufacturers of metal-on-metal hip implants to carry out post-market surveillance studies. The FDA has issued a total of 145 orders for post-market studies to 21 manufacturers, who are now required to ...
The UK's Medicines and Healthcare products Regulatory Agency (MHRA) issued a Medical Device Alert yesterday, warning that several models of CT scanner tables manufactured by Philips Healthcare are prone to collapse when patients are on them. The ...
It is “staggering” how many manufacturers fail to fully fulfil their legal responsibility to collect product data in the post-production phase. That is the view of Steve Owen , Head of Devices Policy, European and Regulatory Affairs, at the UK ...
The deadline for comments to the Global Harmonization Task Force discussion paper on Unique Device Identification (UDI) is being held on 31 March 2010. Jim Willmott explained to delegates at the Future of Medical Device Regulation meeting in London ...
The EU medtech industry is working through the various medical device trade associations to put together a joint industry response to the Global Harmonisation Task Force discussion paper on a globally accepted unique device identification system ...
