October 10, 2014 by Brad Perriello
Medical device makers looking to bring new products to the European market will find a new layer of regulation before they can attain CE Mark approval.
The European Commission’s new hazardous substances restrictions now apply to medical devices for the 1st time, requiring that all products coming to the E.U. market after July 22, 2014, meet materials standards before they get market approval.
By Stewart Eisenhart, Emergo Group
The European Commission has published new guidance on how manufacturers, regulators and Notified Bodies should assess potential risks posed by nanotechnologies used in an increasing number of medical devices.
Scottish health regulators are looking to curb use of transvaginal mesh products while independent investigators look into claims that the medical implants hurt women.