Tomorrow, the European Commission is going to propose and discuss with EU member state health ministers at the Council of EU EPSCO meeting a series of staggered delays for the application of the MDR. Its policy actions have been released in an eight-page document from the Health Council ahead of the meeting in what is described as an “information note” from the commission.
Action is considered urgent by all stakeholders because of the bottlenecks at notified bodies, the third-party auditors who review medtech products, and the fact that an increasing number of devices...