TEAM-NB Survey Shows Slow But Promising Progress Towards MDR/IVDR Certification

Manufacturers are creating their own delays by failing to submit the correct technical documentation to notified bodies. Nevertheless, the latest Medical Device Regulation amendment looks set to ensure compliance against new deadlines is tenable, a recent survey shows.

The EU medtech sector still faces challenges when it comes to organization of its resources and the need to move swiftly; but the EU notified body industry association, TEAM-NB, believes “complete numbers” of products being in conformity with the new Medical Device and IVD Regulations by the new deadlines are achievable.

According to its latest survey, they are only attainable, however, if manufacturers proceed now with their applications to ensure...