The recently released guidance on classification of medical devices is very concerning for manufacturers with spinal implantable medical devices. MDCG 2021-24 appears to have classified many spinal fusion devices that were previously thought to be Class IIb as Class III. This means a more intense application process, closer scrutiny from notified bodies, and a significant resource investment into reclassification.

Background on Spinal Implant Classification

The classification rule in EU MDR Annex VIII states: 

“All implantable devices and long-term surgically invasive devices are classified as class IIb unless they...are spinal disc replacement implants or are implantable devices that come into contact with the spinal column, in which case they are classified as class III with the exception of components such as screws, wedges, plates and instruments.”

For many manufacturers, the up-classification of spinal implants was not entirely unexpected news because reclassification alarm bells have been ringing since the draft regulation was released in 2013. However, when the EU MDR regulation was published in 2017, the language left room for interpretation. In the absence of official guidance, manufacturers considered many of their spinal implants Class IIb based on the exceptions listed in the EU MDR. This was reinforced in 2018 by a Joint NB-Position Paper on Spinal Classification per the MDR. This position paper concluded that spinal fusion devices are Class IIb and non-fusion devices are Class III.

The new MDCG 2021-24 guidance, however, contradicts the Team NB opinion since "Device placed in the disc space," "Interbody fusion devices," and "Spinal implants: hooks that fix the rod on the spinal column" are included as examples of Class III devices. This is important since the MDCG is considered the official interpretation of the law. We know from experience that notified bodies closely follow the MDCG documents.   

Impacts of MDCG 2021-24 on Spinal Implantable Devices

The differences between a IIb and III classification have a major impact on the effort required to achieve compliance with EU MDR. Another factor in the mix is whether the device is also exempted from other requirements, such as implant cards, clinical investigations, and full sampling of the technical documentation. Exempted devices according to the EU MDR include sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors. If fusion cages are not considered wedges for classification purposes, it follows that they may not be considered wedges for exemption purposes.

Similarly, the Joint NB-Position Paper on Spinal Classification per the MDR regulation concluded that spinal fusion devices represent the current state-of-the-art (WET: Well-Established Technology). As such, WET fusion devices, such as basic interbody fusion cages, would be sampled following the typical rules for class IIb devices (at least one representative technical documentation per generic device group) and exempted from Article 18 (implant cards). Devices determined to be WET also offer the benefit of allowing clinical evaluation based on data from similar devices without performing clinical investigations on the subject device.

 

Class IIb WET*

Class IIb (Not WET*)

Class III

Conformity Assessment

One representative sample per device group (Sampling) 

100% sampling – like Class III

Full review of all technical documentation 

Clinical Consultation Procedure (Expert Panel) 

N/A for these devices

N/A for these devices

Required per Article 54

Implant Cards (PIC, PIL)

Required unless exempt 

Required

Required 

SSCP* patient section is needed for implantable devices that require an implant card and class III that are used by patients

Required for implants

Required for implants

Required for implants

Clinical strategy

Leverage similar device data; other data sources

Need data on equivalent or subject device

Need data on equivalent or subject device


What does it mean for manufacturers?

Some of the changes that will have the most significant impacts when reclassifying an implantable Class IIb exempted to Class III include:

  • Need for a full review of the technical documentation instead of sampling one representative device per group (see Article 52.3 and 4). 
  • Need for a clinical evaluation consultation associated with the CER (see Article 54).
  • Need for an implant card (see Article 18) and a patient portion of the SSCP (MDCG 2019-9). Ensuring that implant cards are provided to patients may be particularly difficult due to the way many fusion implants are provided to hospitals and since hospital clinicians may not be aware of the update to classification and need for implant cards.
  • Need for a clinical investigation (see Article 61.4 and 6).
  • Need for clinical data for the subject device or an equivalent device if it is no longer considered WET (see MDCG 2020-6).

This closer scrutiny translates to more resources across multiple departments:

  • Regulatory teams will need to spend more time on technical documentation.
  • Clinical teams will need to gather and analyze the appropriate data.
  • Product teams will need to include patient implant cards in every package.
  • Marketing teams will need to ensure compliant patient information is on the website.

Reclassification also has an impact on manufacturer budgets. For example, instead of sampling from a device group, manufacturers will now have to pay for a review of all devices. The inclusion of a patient implant card will also have an impact on the costs associated with packaging.

Next Steps for Manufacturers

With submission deadlines fast approaching, spinal implant manufacturers are scrambling to assess their needs and make the necessary changes. For manufacturers that have thousands of potentially affected part numbers, this is no small task.

Reassess classifications.

Manufacturers should take a close look at any spinal implants that are currently classified as Class IIb to determine whether the new MDCG guidance affects the classification. 

Develop a clinical strategy.

For devices that do need to be reclassified, the clinical strategy will also likely change. This is especially true for devices that may no longer be considered exempt. Start by performing a gap analysis to determine what steps must be taken next and review the definition of WET in MDCG 2020-6.

Coordinate with notified bodies.

Many manufacturers have already submitted preliminary applications and agreed on classifications for implantable spinal devices. In light of the new guidance, they will have to address reclassification with their notified bodies to determine the best strategy for updating in-process submissions.    

Gather clinical evidence.

Upgrading to a Class III classification may increase the scrutiny of the clinical evidence, especially in conjunction with the loss of any exemptions. Manufacturers will now most likely need to provide data on their own devices and have a strong PMCF plan in place.  

Update technical documentation.

Reclassification creates a ripple effect on any EU MDR submission, and manufacturers need to ensure that all of their technical documentation and supporting documents are updated accordingly. Every element of technical documentation refers to the device class, so this will require a significant time investment for manufacturers with hundreds or thousands of affected SKUs. 

Update clinical reports.

Clinical evaluation plans, clinical evaluation reports, and post-market clinical follow-up plans and reports will also need to be updated based on reclassification. Unfortunately, this is not as simple as finding and replacing text. The clinical team will need to update these documents based on the new strategy. 

Submit or resubmit documentation.

Depending on where manufacturers are in the process, they will need to get on the schedule with notified bodies with a new submission or updated documentation for submissions in progress. 

How RQM+ Helps

MDCG 2021-24 dropped a bomb on the industry, and we know that not all manufacturers have the internal resources or expertise to quickly pivot, reclassify devices, and handle all of the related changes that ensue. The RQM+ team has the knowledge and experience to provide help where you need it, whether it’s updating specific components of your technical documentation or managing all aspects of reclassification. We can help with every step outlined above so your team can stay focused on keeping all of your submissions on track.

The need to quickly obtain patient-level data on each device is likely to be a stumbling block for many manufacturers as they go through reclassification. To support this requirement, RQM+ offers a range of survey services, including:

  • General survey with HCP respondent, without panel    
  • General survey with HCP respondent, with panel    
  • Patient respondent survey
  • Patient chart review 

The type of survey (or combination of surveys) that makes the most sense for your device depends on a number of factors, including device classification and the level of data quality required. It’s also important to note that surveys may not be the only clinical evidence required, but they can allow you to gather data relatively quickly. When it comes to clinical strategy, we can help you determine the business-balanced approach that makes the most sense for you.

If the publication of MDCG 2021-24 has your team reeling, get in touch today to see how RQM+ can help. Whether you need clinical, regulatory, or project management support, we’re here for you.  

Need more help with MDR documentation? Download our MDR Filtering Tool. This handy spreadsheet enables you to filter lines of the EU MDR by topic, section, and search term.

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