Bioexcelife
If you think getting CE certification is just a process—think again.
The latest EU Notified Bodies Survey 2026 reveals a growing challenge in the medical device industry:
more applications, but fewer approvals.
For manufacturers, this is not just data. It’s a clear signal that the bar for compliance has been raised—and it’s getting harder to clear.
The Reality: More Submissions, Fewer Certifications
The numbers tell a powerful story.
Thousands of MDR applications are being submitted. However, only a portion of them are getting certified. The same trend is even more visible in IVDR.
This growing gap shows one thing:
Certification is no longer just about submitting documents. It’s about submitting the right documents.
Why Are So Many Applications Delayed?
The problem is not always complexity. In many cases, it’s preparation.
Notified Bodies are seeing recurring issues such as incomplete documentation, weak clinical evidence, and incorrect classification. Even small gaps can lead to major delays.
As a result, companies are stuck in long review cycles, facing repeated queries and resubmissions.
IVDR: The Bigger Challenge AheadIf MDR is tough, IVDR is tougher.
Many IVD manufacturers are still transitioning. Meanwhile, deadlines are approaching fast. Notified Bodies have limited capacity, and application volumes are rising.
This creates a serious bottleneck.
Companies that delay today may struggle to enter or stay in the EU market tomorrow.
A Clear Shift in Notified Body Expectations
Notified Bodies are no longer just reviewers. They are evaluators of your entire regulatory strategy.
They expect:
- complete and well-structured technical documentation
- strong clinical and performance evidence
- correct classification from the beginning
- early and proactive engagement
In short, they expect clarity, consistency, and confidence in your submission.
What This Means for Manufacturers
The message is simple but critical.
If you wait until deadlines approach, you risk delays.
If your documentation is weak, you risk rejection.
If your strategy is unclear, you risk losing market access.
However, companies that act early and prepare well can move faster and stay ahead.
The Smart Approach: Start Before You Submit
Successful companies are not waiting for problems. They are solving them early.
They review gaps in advance. They align documentation. They build strong clinical strategies. And most importantly, they prepare their submission like it will be challenged—because it will be.
How Bioexcel Helps You Stay Ahead
At Bioexcel, we help manufacturers turn complex regulations into clear, actionable strategies.
From gap assessment and technical documentation to Notified Body readiness, we ensure your submission is not just complete—but competitive.
Because in today’s environment, being compliant is not enough.
You need to be approval-ready.
The 2026 survey is not just a report. It’s a reality check.
The EU regulatory landscape is becoming more demanding. Certification timelines are tightening. Expectations are higher than ever.
The question is no longer “Can you apply?”
It is “Are you ready to be approved?”
Planning MDR or IVDR certification?
Partner with Bioexcel and move forward with clarity, confidence, and speed.
