Certain spine devices were hit with a surprise high-risk Class III designation in a recent EU guidance, forcing companies to regroup on their regulatory strategies. Experts from consulting firm RQM+ discuss the policy, its implications, and next steps.
Spine device companies are scratching their heads over a surprise entry in a recent EU guidance document.
Firms have been operating on the understanding that some widely used spinal implants, including fusion cages and other spine system elements, will be regulated under the Medical Device Regulation as Class IIb devices. But the European Commission’s Medical Device Coordination Group (MDCG) now says otherwise. A broad-ranging classification guidance it published in October dictates that cages and similar devices that contact the spinal column are high risk, Class III in the eyes of the MDR. The Class IIb vs. III distinction has very practical implications for companies, ones that are particularly inconvenient to be coming clear now about six months after the MDR went live.