Device regulation in disarray

Faulty medical implants investigation: ‘A system in disarray that favours manufacturers at the expense of safety’

In terms of regulation, the role of the European Union is to ensure the highest level of patient safety. But what has been found out by the Telegraph and the BMJ’s investigation now puts this claim in serious doubt.

To put it bluntly, device regulation is in disarray: the evidence requirements at the time of approval are woeful, the conduct of notified bodies is sub-standard, and individuals supposedly representing the regulatory system are conflicted and in many cases under-qualified. read more in theTelegraph

You can also read the main investigation by Holly Watt and Claire Newell, of the Telegraph, which details the  faulty medical implants investigation.

In addition, Jeremy Hunt, the Health Secretary, outlines what the UK goverments repsonse will be: ‘Like many people, I was shocked and appalled to read in The Telegraph that a regulator in Europe said that it was “on the side of the manufacturer” when it comes to licensing products — such as hip replacement.’

Its a simple problem and its not that complex; at the time of device approval most devices have no clinical evidence.