Why Incorrect Classifications can be Costly for Manufacturers
Correct classification according to MDR is the basis of any regulatory strategy. If it is incorrect, the entire compliance approach is often affected, from technical documentation to market availability.
In our consulting practice, we are increasingly seeing cases where products are not classified correctly, usually not due to negligence, but because of incorrect assumptions or misunderstood definitions.
Why Misclassification Occurs
Typical causes are:
- Assumptions such as ‘That's definitely Class 1’
- Unclear definitions (e.g. diagnosis, monitoring, intended use)
- Transfer of old MDD logic to the MDR
- Borderline cases involving software, accessories or product combinations
Even a single misjudgement can result in the entire MDR strategy being built on false premises.
Why this is Relevant Today
Under MDR, authorities and notified bodies check much more closely.
Misclassification is often detected in:
- market surveillance measures
- Audits by notified bodies
- product registrations
- Vigilance and PMS activities
Class 1 products are also regularly the focus of attention.
What this Means for Manufacturers
In practice, misclassification often leads to:
- Sales stoppages or delays
- extensive additional requirements regarding evidence and tests
- unexpected project costs
- Loss of trust in authorities and partners
Particularly critical:
In these cases, the technical documentation is almost never MDR-compliant because it is based on an incorrect classification.
Why Early Classification is Crucial
A clear classification determines not only the product class, but also:
- the entire conformity process
- the involvement of a notified body
- Scope and depth of technical documentation
- realistic time and cost planning
If you would like to have your classification verified by experts or review it during the course of the project, we can assist you with classification and the derivation of a suitable MDR strategy.
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