The Risks of Misclassification in Medical Devices: Why Getting It Right Matters

Correct classification is the foundation of medical device compliance. It determines the regulatory pathway, the level of scrutiny, the depth of technical documentation required, and the evidence needed to demonstrate safety and performance.

Both the MHRA and EU authorities are ramping up oversight and identifying more products on the market that do not meet the correct classification rules.

For manufacturers, the consequences can be significant: forced product withdrawal, regulatory penalties, reputational harm, and major operational disruption.

This article explains why misclassification happens, the risks involved, and how to avoid making costly mistakes.

Why Misclassification Happens

Misclassification is rarely intentional. Most cases occur because manufacturers:

• May be unfamiliar with the full classification rules in their target jurisdiction.
  
• Do not understand the definitions that determine classification.
  
• Misinterpret guidance documents.
  
• Assume a device is “low risk”.
  

Misunderstanding a single definition such as “custom-made,” “diagnosis,” or “monitoring” can drastically alter the required evidence, documentation, and testing.

This is a regulatory risk and a business risk.

Use the definitions first, then the rules.

This applies across:

• EU MDR
  
• IVDR
  
• UK MDR 2002
  
• MHRA software flowcharts
  
• MDCG classification guidance (e.g., MDCG 2021-24)
  

These resources translate abstract rules into practical examples and help prevent interpretation errors.

The Regulatory Consequences of Misclassification

Misclassification is not a minor administrative error. Regulatory authorities treat it as a compliance breach, and the consequences can be severe.

Manufacturers risk:

a) Forced product removal from the market

Authorities may instruct immediate withdrawal of the device if it is illegally placed on the market.

b) Full or partial product recall

Depending on risk, the MHRA or an EU Competent Authority may require a recall to protect patient safety.

c) Sales pause and business interruption

Companies may be forced to halt sales while reclassifying, retesting, and updating documentation, resulting in significant commercial loss.

d) Fines, penalties, and reputational damage

Misclassification is legally equivalent to non-compliance with medical device regulations. Consequences can include financial penalties and long-term reputational harm.

e) Notified Body escalation

Notified Bodies are obligated to inform Competent Authorities if they detect a misclassified device. Once notified, regulators take control of the corrective actions required.

When Authorities Are Most Likely to Spot It

Oversight from the MHRA has intensified. Common triggers include:

• Market surveillance inspections
  
• Device registration reviews
  
• Import checks
  
• Notified Body audits
  
• Post-market vigilance investigations
  

Manufacturers should not assume that Class I products will “fly under the radar.” Even self-certified devices must meet the same legal requirements for evidence, documentation, and declarations of conformity.

Misclassification Affects Documentation and Testing Requirements

When a device is misclassified, the technical documentation is almost always insufficient. 

This can affect:

• The depth of clinical evidence
  
• The risk management file
  
• The type and extent of bench testing
  
• Software validation and cybersecurity activities
  
• Usability engineering
  
• Post-market surveillance requirements
  

Classification dictates the entire compliance pathway, which means incorrect classification results in incorrect or incomplete evidence.

Patient Safety Risks

Misclassification is not just a regulatory problem, it can directly affect patient safety.

If a device is classified as Class I but the technology actually places it in Class IIa or IIb, the product may reach the market:

• Without the required level of clinical evidence
  
• Without appropriate performance testing
  
• Without Notified Body oversight
  

This increases the likelihood of harm to patients and users..

What To Do If You Discover Your Device Is Misclassified

Manufacturers have a much stronger position if they identify and declare the misclassification before regulators do.

Recommended steps:

1. Stop sales temporarily, if required.
   
2. Assess the classification and seek regulatory guidance.
   
3. Withdraw the device and prepare proper documentation.
   
4. Rebuild evidence, testing, and technical documentation to meet the correct class.
   
5. Re-enter the market only after the correct conformity assessment has been completed.
   

Authorities respond far more favourably to proactive correction than to being “caught out.”

How to Avoid Misclassification in the First Place

Practical advice:

• Read the legislation and guidance (MDR, IVDR, UK MDR, MDCG docs).
  
• Use flowcharts such as the MHRA and MDCG software classification tools.
  
• Check definitions carefully, they dictate everything.
  
• Seek expert regulatory advice early.
  
• Triple-check your classification before registering a product.
  
• Monitor regulatory intelligence, as classification rules evolve over time.
  

Misclassification is far more costly to fix than to prevent.LFH helps manufacturers classify devices correctly under MDR, IVDR, and UK MDR, preventing costly mistakes and ensuring smooth market access. From classification assessments and regulatory strategy to technical documentation and audit preparation, our consultants provide clear, reliable guidance tailored to your device.

FAQs – Misclassification in Medical Devices