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Team-NB recently released a position paper regarding the classification of devices to detect SARS-CoV-2. These devices are currently cited in the MDCG 2020-16 classification guidance as an example of a device falling under Rule 1, 2nd indent, which states:
"Devices intended to be used for the following purposes are classified as class D: detection of the presence of, or exposure to, a transmissible agent that causes a life-threatening disease with a high or suspected high risk of propagation."
Team-NB has outlined the factors to be considered for the classification of SARS-CoV2 according to this rule, which includes incidence, transmission, pathogenicity, mortality, and morbidity. During the SARS-CoV2 pandemic, the conditions required in Rule 1, Indent 2 for a transmissible agent at high risk of propagation as well as able to cause serious illness were met. However, since SARS-CoV2 is no longer a public health emergency, these conditions must be reassessed.
The requirements to classify IVDs for SARS-CoV2 as a Class B or Class C are examined in the paper. Ultimately, Team-NB contends that these devices may be downgraded from Class D to Class C. A reclassification to Class C was endorsed rather than Class B due to the remaining risk of SARS-CoV2 for vulnerable populations. In other words, the transmissible agent could still result in life threatening illness for certain populations and therefore, rule 3c applies (detecting the presence of an infectious agent, if there is a significant risk that an erroneous result would cause death or severe disability to the individual, fetus or embryo being tested, or to the individual's offspring).
The ability to adjust the list of high-risk agents makes sense when considering the wording of the rule itself. If a new infectious disease with a suspected high risk of propagation emerges, it can fall under rule 1 until a time when the scientific evidence has shown it no longer meets both requirements. Under a similar rationale, agents that were once at a high risk of propagation and/or causing life threatening illness, may be downgraded once the pandemic is under control, as is being suggested for SARS-COV2. In fact, it is incorporated directly into the guidance MDCG 2020-16. A note is included under Rule 1, 2nd indent indicating that the list of high-risk agents may be updated based on new scientific data. However, there has yet to be an example of this type of classification change. An update to the guidance to align with the Team-NB position would be the first of its kind under IVDR.
This Team-NB paper puts into writing a topic that has been on the minds of stakeholders in the IVD industry for many months and provides a rationale for adjustment of the classification for SARS-CoV2 devices. Many people in the industry have been having discussions on this very topic and wondering if there is an opportunity for a change of classification and an easier path to the EU market for SARS-CoV2 devices. The Team-NB paper opens a door that could have far reaching benefits for manufacturers, notified bodies, and ultimately patients by reducing the barriers to market for the devices in the EU.
While there is a pathway for change based on the language in IVDR Annex XIII classification rules as well as the MDCG 2020-16 classification guidance, there are many considerations and complexities in the practical implementation of this change. It is likely that with the release of the Team-NB paper, notified bodies are already thinking ahead to these factors (even if only abstractly). The following must be considered for key stakeholders to appropriately respond to any changes in classification of SARS-CoV2 IVDs.
1. Legal Manufacturer Adjustments
Legal manufacturers will need to update SARS-CoV2 technical files to reflect the classification change. This activity could become quite complex depending on where in the IVDR transition process they are. Other documents may also be impacted and require updates. For example, procedures that specifically mention Class D requirements need to be assessed.
2. Notified Body Considerations
Many of the consequences of this change will fall on notified bodies to sort out. Notified body certification schemes are different for Class D versus Class C/B devices. Class D devices require technical documentation assessment certificates whereas Class C devices (that are not Near patient tests or self-tests) are covered under a quality management system certificate and devices on these certificates are placed into generic device groups based on intended use and technology. How will this be managed if these IVDs are downgraded? Will any issued Class D technical documentation assessment certificates be cancelled or voided? Similar questions exist for devices currently undergoing conformity assessment. What happens with the ongoing technical reviews for SARs-Cov2 assays? Will the manufacturer be required to update technical documents to reflect the new classification before the review can continue? If the device falls into a group that is already certified, then what happens with the ongoing review?
There are also questions in regards to batch release. Class D devices require batch release by the notified body and are expected to be subject to testing by European Reference Laboratories (EURLs) by the end of 2024. For any devices certified before a classification change is made, how would these devices be transitioned away from batch release requirements?
We must also consider the potential upside for notified bodies. A reduction in classification from Class D to Class C will free up valuable resources to continue working on the IVDR transition. Since all Class D devices require technical review, the total number of technical reviews will ultimately decrease as SARS-CoV2 IVDs will be sampled as part of the generic device group. In addition, notified bodies will not have to allocate resources to batch review or to PSUR review for these IVDs once they are certified.
3. Common Specifications Reevaluation
The common specifications for SARS-CoV2 IVDs must also be considered. The Implementing Regulation (EU) 2022/1107 for common specifications is specifically applicable for class D devices. What is the applicability of the common specifications in the event that COVID assays are downgraded to class C? Will the implementing regulation be updated to remove SARS-COV-2, or will they be updated to remove the Class D specificity currently within the document? Will there still an expectation that they be followed as this is now considered state-of-the-art? This is an especially important question for manufacturers who may have devices in product development, especially those planning and executing clinical trials for a SARS-CoV2 IVD.
4. Classification Update Process
A change in classification of SARS-CoV2 and potentially other analytes in the future, is likely to be triggered through an update to the MDCG 2020-16 classification guidance. However, the process to update this document and then introduce these changes throughout the notified bodies takes time. In the event that SARS-CoV2 (or other pathogens) must be up-classified back to Class D, can the system respond with haste to ensure patient safety. All of the concerns cited above become even more relevant but in reverse.
Conclusion and stay updated with rqm+
The Team-NB position paper outlines a pathway that would reduce regulatory burden for manufacturers of SARS-CoV2 devices and alleviate some burden on notified bodies, but there are still many practical considerations that will be triggered if it is brought to fruition.
RQM+ will continue to watch this space closely, and continue to update, analyze, and provide guidance to stakeholders for any future updates on this topic.
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