EU Parliament Considers More Stringent Medical Device Regulations

EU Parliament Considers More Stringent Medical Device Regulations-graysheet: Continuing the argument from the committee’s Feb. 26 meeting, Dagmar Roth-Behrendt of Germany, the rapporteur of the committee, advocated that a more extensive pre-market approval process should be created for Europe. “I want to have a centralized pre-market authorization for the highest class [of medical devices],” she said in her opening remarks. (See "Pre-Market Question Attracts Debate At EU Parliament Session On Device Reforms" — "The Gray Sheet," Mar. 11, 2013.) “Doctors insist on pre-market authorization,” she said later.