IVDR reality check: are we moving fast enough?

As of February 2025, approximately 1,500 IVDR certificates have been issued. That’s progress — but is it enough? With an estimated 18,700 devices still requiring certification before the end of 2029, the current pace raises serious concerns. 

Let’s break it down:

• At the current rate, we’re on track to reach only ~7,500 certificates by 2029.
• To keep all products on the market, we may need closer to ~18,700 certificates.¹
• That means we must scale up efforts 3–4X faster than today.

Figure 1. IVDR certification data ², trend and estimated pace to reach the target

How long does IVDR certification take?

Survey data² reveals the typical timelines from signing a written agreement with a notified body to receiving the certificate:

• QMS (Quality Management System) certificates:
  • 55% of notified bodies issue them in 6–12 months
  • 27% take 13–18 months 
    
    
• QMS + Product certificates:
  • 64% take 13–18 months
  • 9% take 19–24 months

In practice, most certifications take 1 to 1.5 years, and sometimes up to 2 years, depending on the scope (QMS only vs QMS + product).

Interestingly, 61% of the total certification time is spent with manufacturers, not notified bodies. This is largely due to the time required to revise and improve documentation and technical files before approval.

There’s still time — but many IVD manufacturers may be thinking the same thing. This means that waiting too long could mean missing the window for certification and risking market access.

How we can help

We support IVD manufacturers in navigating the IVDR landscape with services tailored to accelerate readiness:

• Classification
• QMS compliance
• Performance evaluation
• Post-market surveillance
• Gap analysis & auditing
• Technical documentation
• Training

Let’s work together to ensure your products stay on the market — and ahead of the curve. Contact us so we can discuss your specific needs.

References

1. There are several sources for estimating the number of IVDDs on the market and those expected to be certified under the IVDR. These include the European Commission Proposal COM(2021) 627 final (October 2021), which amended the IVDR transitional provisions; MedTech Europe (2023), IVDR Survey Public Report; and the Monitoring the Availability of Medical Devices and In Vitro Diagnostic Medical Devices in the EU Dashboard. The estimation used in this scenario is a rough figure, considering already certified IVDs, to illustrate the order of magnitude.

2. European Commission (2025). Study supporting the monitoring of the availability of medical devices on the EU market: Survey results of the 14th NB survey (MDR/IVDR), data status 28 February 2025. Brussels.