Non-conformity: a disaster in the European statistics
That is what a 2024 survey of notified bodies (NBs), conducted on behalf of the European Commission, reveals.
Of the 48 MDR-designated notified bodies that responded, 38 say that fewer than half of the files they receive are complete on receipt.
And the main causes identified among the NBs' reasons for refusal? Misclassification of the device, an application outside the NB's designation scope, and, at the top of the list, the incomplete file itself.
One of its causes? A lack of traceability.
Incomplete traceability → Incomplete file → Certification delays → Danger
In other words, most of the time:
Not a problem of willingness – A problem of systems.
When:
- Your batch records live in Excel files that can end up scattered,
- Your non-conformities are managed on paper,
- Tracing a problematic component takes 3 days to reconstruct,
You fall behind.
And falling behind can be dangerous – An audit does not forgive.
We built Arianis for exactly this
To give you the assurance that your system covers all the compliance requirements. Complete production traceability, Built-in quality controls, Consolidated batch records, Automatic alerts.
For a complete certification file.
Find out more at cerebellis.com/en/arianis and request a demo: those few minutes could save you from losing a certification that is vital to your business.
