The EU notified body industry association, TEAM-NB, and the European Confederation of Notified Bodies Group (NB-Med), have drafted a position paper in a bid to clarify how to apply the EU MDR's regulatory provisions on spinal implants. The document features a risk-based decision tree to demonstrate whether spinal implants – both fusion and non-fusion devices – should be in risk class IIb or III. This will determine the amount of work that needs to be done.
Their joint work was prompted by the complex wording used in Classification Rule 8 of the MDR (contained in Annex VIII, 5.4), on implantable devices and long-term surgically-invasive devices. The two groups felt that this impeded a harmonized interpretation of the regulation, and moreover that it lacked clarity regarding the level of scrutiny that notified bodies would need to apply when overseeing the manufacturers of such devices.
EU MDR Annex VIII, 5.4. Rule
This states that all implantable devices and long-term surgically-invasive devices are in class IIb unless they:
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are total or partial joint replacements, in which case they are in class III, with the exception of ancillary components, such as screws, wedges, plates and instruments; or
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are 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.
There are many complexities around this, however, as are listed in the Position Paper.
Comments And Corrections Welcomed
The two organizations say that “with this position paper, notified bodies are providing their view and interpretation to the various EU regulators, including the European Commmision, enabling them to comment and correct if deemed necessary.”
The authors of the position paper believe that the decision tree will reduce the number of unnecessary submissions for clinical evaluation consultation, a regulatory process involving a close scrutiny reserved for the highest-risk devices.
This, they say, is in line with the intended focus of the planned expert panels – on novel devices and devices with possible major clinical or health impacts.
“With this measure,” the authors add, "a smaller number of experts at the panel are needed, reducing the burden on the EU Commission to establish such an expert panel within a short period of time.”
They offer the following decision-tree on spinal implant classification:
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Risk class
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Type of technology
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Degree of review
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IIb
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Fusion devices
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a)
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Well-established technologies
- Devices that are exempted from Article 18
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To be sampled according to typical rules for class IIb devices (at least one representative technical documentation per generic device group)
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b)
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Not so well-established technologies:
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Full review of technical documentation, similar to class III devices (100% sampling)
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- New technology regarding manufacturing processes, material, innovative design, complex design (eg 3-D printed devices)
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- Multiple components or complex wedges, spacers, pins and screws (e.g. expandable)
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- Devices with high clinical risk (e.g. pediatric surgery devices)
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III
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Non-fusion devices(eg dynamic fixation)
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Subject to a clinical evaluation consultation procedure, including review by an expert panel as part of the scrutiny procedure
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