News

Telegraph reports on new European regulations

A story published in the Telegraph details the new rules that are being drawn up as a result of the metal-on-metal and the PIP breast scandal to allow more transparency regarding the safety aspects of the devices. Currently all clinical evidence and details on adverse incidence are not available to the public. This allows the manufacturers to protect their commercial interests rather than putting patient safety first. Under the new regulations this data would become freely available.

Another important aspects is that companies can currently have their products checked by notified bodies in any of 27 EU member states. As the quality of these checks varies from country to country the MRHA recommends urgently changing the system to mean that accreditation is done in several countries to standardise the process. Full article available from here

Last modified: Fri, 15 Feb 2013 15:56:30 GMT