IVDR classification: Why so many devices are being misclassified and why the risk is bigger than you think
As the IVDR transition continues, one issue keeps coming up during Notified Body reviews: Devices are being misclassified.
At DNV, we’re increasingly seeing devices submitted as Class B that, once reviewed in detail, need to be classified as Class C. At first glance this can feel like a technical detail, but under IVDR it’s much more than that. Getting the classification wrong can have serious regulatory and commercial consequences and, in some cases, it can even put continued market access at risk.
So why is this happening? What has really changed under IVDR, and what should manufacturers be doing now to avoid unpleasant surprises?
Why is misclassification happening more often under IVDR?
Under the former IVDD, classification was often relatively straightforward. Under IVDR, it is not and here is why.
1.“Life-threatening” is not clearly defined
Several IVDR classification rules, including 3(c), 3(g), and 3(j), refer to “patient management decisions resulting in a life-threatening situation.”
However, IVDR does not define what “life-threatening” means. In practice, this is highly context dependent. What is life-threatening for an immunocompromised patient may not be for the general population. A screening test carries very different risk compared to a monitoring test used in patients with a diagnosed condition.
Manufacturers are now expected to make, and justify, these risk judgements explicitly. Many underestimate this obligation, often applying legacy IVDD thinking, which can lead to Class B assumptions where Class C is more appropriate.
2. The intended purpose of the device is no longer a simple description
Another common issue is an overly narrow or incomplete intended purpose. Under IVDR, it is no longer sufficient to state for example:
“The device measures clotting factor XII.”
Manufacturers must define the clinical population and clinical use, for example:
“Measurement of clotting factor XII to aid in the diagnosis, monitoring, and management of coagulation disorders in patients on anticoagulation therapy, including hereditary factor XII deficiency and associated bleeding or thrombotic risk.”
This matters because classification is driven by risk and risk is driven by clinical context. A false negative in a healthy screening population may have limited impact, while the same result in a patient with a bleeding disorder could be life-threatening, potentially shifting classification from Class B to Class C.
3. Controls are not automatically Class B
Controls are often assumed to be Class B under Rule 7, but this is not always the case. Key questions must be considered: Is the control intended for use with a specific device? Does it provide quantitative or qualitative values? And could incorrect control results affect patient management decisions?
In several cases, these factors have legitimately moved devices from Class B to Class C, often unexpectedly for manufacturers.
The consequences of getting classification wrong
- Loss of market access after May 2026
Under Article 110, late applications are not accepted. If a legacy IVDD device is misclassified and has not applied for IVDR certification in time, it cannot continue under the transitional provisions and cannot be legally placed on the market. This could mean that products need to be withdrawn until certification is achieved. - Severe commercial impact
Misclassification can lead to long delays, higher certification costs, supply chain disruption, and contractual penalties. Even short market interruptions can be damaging. - Limited Notified Body capacity
Thousands of manufacturers require IVDR certification, yet fewer than 20 Notified Bodies are designated. Capacity is tightly regulated, and waiting too long, even with a Class B device, is a significant risk.
What if a manufacturer disagrees with the classification?
As with MDR, manufacturers can appeal a classification decision via their Competent Authority, whose determination must be respected by both the manufacturer and the Notified Body. However, this process can take several months, be costly and introduce uncertainty into certification timelines.
Our recommendation: Engage early, even if you believe your device is Class B
IVDR has raised the bar to improve patient safety through better risk understanding. Misclassification is rarely intentional; it usually stems from legacy assumptions, underestimating intended purpose, or regulatory ambiguity. The key lesson from IVDR implementation so far is clear: classification can’t be treated as an administrative formality. Early engagement allows assumptions to be tested, intended purpose to be refined, and certification planning to become realistic rather than reactive. In many cases, submitting devices together can also streamline the process and reduce administrative burden.
To device manufacturers and the consultancies advising them, our recommendation is clear. The risk of misclassification under IVDR should be on your radar. The commercial consequences are real, and the timelines are unforgiving. But with the right expertise and early engagement, these risks are manageable and avoidable.
Get in touch to start a structured dialogue and ensure your device is correctly classified, before risk becomes disruption.
12/18/2025 8:33:00 AM
