Issues such as the 1,000s of faulty breast implants provided to women in France and the U.K. are indicative of a weak foundation for medical device approval, said challengers of the European Union’s CE Mark med-tech approval process.
Under the CE Mark system, regulatory authorities have no control over the how devices are actually made, relying on "design specifications" to render approval decisions, patient safety expert Brian Toft said in a meeting with U.K. health minister Simon Burns in September 2011.