EU Commission NB Survey Shows MDR Applications Slightly Decline While IVDR Applications Continue to Grow
The latest data from the EU Commission 20th Notified Body Survey provide an updated view of the number of applications filed and certificates issued under the Medical Devices Regulation and In Vitro Diagnostic Medical Devices Regulation.
The data, sourced from the European Commission survey dated 2 July 2026, show different trends for MDR and IVDR activity.
MDR Applications and Certificates
The first chart presents MDR applications filed and certificates issued.
According to the visual data, MDR applications reached 32,898 by February 2026, compared with 33,107 in late 2025, representing a 0.6% decline. The same chart shows 18,010 MDR certificates issued by February 2026.
This indicates that, while MDR certification activity remains substantial, the pace of new MDR applications may be stabilising or slightly decreasing after several years of growth.
IVDR Applications and Certificates
The second chart presents IVDR applications lodged and certificates issued.
The data show 3,418 IVDR applications and 2,318 IVDR certificates issued by February 2026. The chart highlights 3% growth in IVDR applications, indicating continued expansion of IVDR conformity assessment activity.
Compared with MDR, the IVDR figures remain lower in absolute volume, but the continued growth reflects the ongoing transition and increasing certification activity for IVD manufacturers.
What the Data Suggest
The survey highlights two important trends for the EU regulatory system.
First, MDR applications appear to be levelling off, with a small decline in the most recent reporting point. Second, IVDR applications continue to grow, suggesting that IVD manufacturers are still moving through the transition toward IVDR certification.
The charts also show a continued gap between applications and certificates issued under both regulations, reinforcing the importance of certification planning, notified body capacity management and timely submission preparation.
Impact on Medical Device and IVD Manufacturers
For medical device and IVD manufacturers, the survey data underline the need for proactive regulatory planning under both MDR and IVDR.
Manufacturers should pay particular attention to:
notified body availability;
application timing;
certificate timelines;
quality of technical documentation;
readiness for conformity assessment;
MDR and IVDR transition planning;
certification renewal strategies;
capacity constraints in the EU system.
For IVD manufacturers in particular, the continued growth in IVDR applications highlights the importance of preparing early and ensuring that technical, clinical and performance evidence is complete before submission.
