NB-Med and Team-NB issued a Joint Position Paper to ensure more harmonized classification of implantable devices and long-term surgically invasive devices under the new MDR (Annex VIII, Rule 8).
Rule 8 lays down a general class risk – IIb, however with eight exceptions that fall under the highest risk class (Class III) and even those have exceptions with wording that allows (too) wide interpretation.
The Joint Paper focuses on the wording of the last paragraph of Rule 8 (see in bold): ”spinal disc replacement implants and implantable devices that come into contact with the spinal column, in which case they are in class III with the exception of components such as screws, wedges, plates and instruments” and presents the NB-Decision tree on Spinal Implant Classification.
The NBs conclude by noting the risk-based approach that a distinction should be made between ”’non-fusion devices that must be classified as class III, and the fusion devices that are exempted to stay as class IIb but divided into two categories:
Category 1 will be sampled following the typical rules for class IIb devices (at least one representative technical documentation per generic device group) Category 2 will be fully sampled similarly to class III devices (Class IIb Implants process as described in the regulation and not belonging to the exemption list)”