IVDR Reality Check: Are We Moving Fast Enough?
As of February 2025, around 1,500 IVDR certificates have been issued. But if an estimated 18,700 devices still need certification before the 2029 deadline, then the math just doesn’t add up.
At the current pace, we might reach only ~7,500 certificates by 2029 — far short of what’s needed to keep all products on the market. To close the gap, the industry must scale up efforts 3–4X. That’s a serious challenge.
Survey data shows:
- QMS certificates: 55% of notified bodies issue them in 6–12 months.
- QMS + Product certificates: 64% take 13–18 months, and 9% take up to 2 years.
Interestingly, 61% of the total certification time is spent with manufacturers, not notified bodies. That means the bottleneck is often internal — in documentation, technical files, and readiness.
There’s still time. But many IVD manufacturers may be thinking the same thing — and waiting could mean missing the window.
Let’s work together to ensure your products stay on the market — and ahead of the curve. Read the full article at Aurevia.com to learn how we support IVD manufacturers.
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