Today the ‘Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)’ was released.
It can be found: HERE
This Manual is not intended to replace other classification guidance documents, such as:
Instead, the Manual is intended to record the agreements reached by the Borderline and Classification Working Group (BCWG), following the exchanges under the Helsinki Procedure.
The Helsinki Procedure is a system ‘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…’
Below is an excerpt of a flowchart, to give a sense of the Helsinki Procedure process.