Borderline and classification case process updated

To allow consultation among competent authorities (CAs) on borderline and classification issues concerning medical devices, and to ensure that appropriate guidance is published in the Manual on Borderline & Classification for Medical Devices (the Manual), the Borderline & Classification Working Group (BCWG) of the Medical Devices Coordination Group (MDCG) has updated the ‘Helsinki Procedure’ first agreed in 2002.

The procedure includes flowcharts and explanations that provide both an overview and the detail of the procedure, which is implemented when a national competent authority (CA) identifies a borderline or classification issue that it cannot resolve by reference to the MDR/IVDR, published guidance documents, or by precedent.

Copies can be obtained from here.