EUCOMED: EXTENDING DRUG CLINICAL TRIAL REGS TO DEVICES A BAD IDEA
A recent trend among some European Union (EU) members to apply clinical trial regulations for medicines to medical devices is ill conceived and not in the interest of device manufacturers, according to a position paper released by Eucomed, the European medical technology industry association.
The association's concern was raised by revelations that some EU countries were broadening the scope of clinical investigation directives that deal with experimental drugs to cover medical devices as well.
While Eucomed said it welcomes some provisions of the pharma directives -- such as simplification of applications to ethics committees -- the group emphasized that devices and drugs are governed by separate regulatory regimes and involve vastly different technologies. "The heterogeneity of medical devices, which encompass products as different as thermometers and implantable pacemakers, renders the application of a medicinal product regulation to medical devices impractical and unnecessary," the Jan. 15 paper said.
The extension of the drug directives is "unnecessary as the current regulatory regime adequately ensures the safety and performance of medical devices," Eucomed said. Moreover, the practice is in conflict with European Community law governing medical devices, the association said.