Interview: How Are EU Notified Bodies Preparing For Designation Under New Regs?

EU notified bodies that want to be among the first designated under the Medical Device and IVD Regulations can submit applications in late November. Francoise Schlemmer, director of TEAM-NB, the EU notified body association, talks with Medtech Insight about what it will take to be ready.

EU notified bodies can start to apply for designation under the EU's Medical Device and IVD Regulations later this year, on November 26 – six months after the two new texts enter into force.

Those that go first will be testing the system. But not shy of a challenge, the EU notified body association,...