On December 7th, 2018, Team NB, an organization of European Notified Bodies (NBs), published a document titled “Joint NB-Position Paper on Spinal Classification per the MDR” that summarizes their opinion on Rule 8 of the EU Medical Device Regulation (MDR) 2017/745. One of the association’s mission is to create non-binding guidance documents that clarify current EU regulations.
Rule 8 classifies spinal implants based on a vague device description that does not consider the various establishment levels amongst the different types of spinal devices. This, in effect, has led to the categorization of all spinal implants into the highest possible medical device class in European Union– Class III, which is associated with the highest risk.
According to ANNEX VIII 5.4. Rule 8 of the EU regulation 2017/745, all implantable and long-term surgically invasive devices belong to Class IIb, except for:
- Devices that are total and partial joint replacements (not including ancillary components, such as wedges, screws, plates, and instruments)
- Spinal disc replacement implants and implantable devices that are in contact with the spinal column (not including ancillary components)
However, spinal disc replacement implants may refer not only to total disc replacement, but also may cover other types of implants.
Spinal Classification EU MDR Model Proposed by Team NB
According to the proposal made by Team NB, implant technologies used in spine surgery should be divided into two groups:
- Fusion devices, which fuse together two or more vertebrae
- Non-fusion devices, which attempt to keep the segmental motion between vertebrae
Fusion devices are considered Well-Established Technology (WET) and non-fusion devices are considered Not Well-Established Technology (Not-WET). The distinction is heavily discussed by the medical societies of spine surgeons and has been the subject of many controversies.
Team NB has proposed that all non-fusion devices be classified as Class III devices and that fusion devices be divided into two categories, with some falling into Class IIb and others falling into Class III.
Such a classification model would reduce the number of unnecessary clinical evaluation consultation submissions (MDR Article 54), allow for risk associated with different implant types to be addressed, and make the process of overseeing manufacturers much clearer for Notified Bodies.
Will Australia Adopt Rule 8 of the EU MDR?
Rule 8 of the EU MDR is not a trending topic in the European Union alone. Australia is also considering adopting the EU’s spinal implant classification model. The Australian Therapeutic Goods Administration (TGA) believes that following the MDR rule would more accurately address device risk, technical design, and the level of invasiveness of these kinds of devices. If implemented, the TGA will make all the necessary changes to ensure that the new classification model properly aligns with Australia’s regulatory requirements for medical devices.
Comments on this proposed change will be accepted through March 31, 2019. If the rule passes, new spinal implant classification regulations will be enforced starting in August 2020.
Spinal implant devices that will potentially be affected by this change include bone grafts, bone screw internal spinal fixation systems, anatomic facet replacement systems, vertebral bone filler, cervical facet joint distractors, and orthopedic cement. More detailed information can be found in the official proposal document that was issued in February 2019.