While each new designation of a notified bodies in the medtech space is good news, many more organizations are needed rapidly to help manage growing demand. Capacity warnings continue.
Bureau Veritas Italia has become the eighth notified body to be designated in Italy under the EU’s Medical Device Regulation and the 32nd in the EU.
The Italian notified body, based in Milan, has been designated for a range of active non-implantable devices and non-active non-implantable...
Now that the US FDA has chosen not to appeal a March ruling effectively killing the agency’s efforts to regulate lab-developed tests as medical devices, will the agency adopt a different strategy to flex its regulatory muscle?
Commissioner Martin Makary told staff that plans are being developed to centralize HR, IT, travel and other functions, which were heavily impacted by the 1 April reduction-in-force.
After two serious injuries and one death linked to some of its ventilators, Medtronic has recalled the devices and asked customers to stop using them and find alternative means. The action comes more than a year after the company left the market.
