ARTICLE SUMMARY:
There has been a noticeable decline in companies approaching notified bodies about IVD Regulation conformity assessments. That has led to the unusual experience of spare capacity, but it’s making notified bodies nervous of what’s to come in 2024.
The standard implementation narrative for EU regulations is there is a lack of capacity at notified bodies to handle the influx of conformity assessment submissions for both existing and new products. But for IVDs, at the moment, the narrative seems to have switched.
Submissions under the EU IVD Regulation have dropped sharply, leaving spare capacity at the 10 notified bodies designated under the diagnostics rule. As a result, some of the notified bodies fear there will be a spike in high-risk (Class D) IVD submissions next year when it’s probably too late to meet legal deadlines for those products.
