Brussels, 01/02/2012 (Agence Europe) - On Wednesday 31 January, the French health minister Xavier Bertrand announced that France would be stepping up requirements for the marketing and monitoring of implants and other medical devices, further to the publication of a report on Poly Implant Prothèse PIP breast implants, according to a report by Reuters. The study calls for this tightening-up of measures to be carried out at both national and Community levels, and recommends “regular surprise inspections” at manufacturers' premises, an opinion which the minister is minded to follow. Nationally, the inspections and vigilance activities of the French agency Afssaps will be reinforced, with an increase in the number of inspectors, more controls and surprise checks both in production premises and healthcare establishments. At Community level, the directive on medical devices, which is due to be reviewed this year, “should be radically overhauled, in order to tighten up major requirements on clinical data to be submitted and their assessment for the marketing of medical devices”, and inspection procedures should also be reviewed, says Bertrand. The minister also stressed that the report highlights the “large-scale deceit” of the company PIP. He has called for a list of at-risk medical devices and proposals for a revision of the monitoring system to be put together by early March. By mid-March, there should also be a report on the state of play and prospects for the use of all silicone breast implants, 10 years after the moratorium was lifted in France. (IL/transl.fl)