New version of the list of regulatory positions and classifications of MDs and IVDs
On January 22, 2016, the ANSM published a new version of the “FAQ” on regulatory positions and classifications of medical devices and in vitro diagnostic medical devices (dated 12/01/2016).
As a reminder, this document is the french equivalent of the “Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices”, Version 1.17, updated September 2015.
Please Note: the new version of the FAQ also contains the “Mise à jour” (updates) previously included in the June 2015 version, which may cause some confusion. There are, in fact, only two new updates; they concern the following products: Insulators for handling pharmaceuticals in hospital and Electric wheelchairs intended for practicing sport. These points have been added to Part II of the FAQ: “Questions relating to the status or class of a product“. There were no additions or changes to Part I: “Questions relating to regulatory procedures“.