In recent years, the term “IVDR bottleneck” has become one of the most widely discussed topics in the medical device industry especially within the In Vitro Diagnostic (IVD) sector. This issue has emerged as a major challenge, affecting product registration, market access, and the global competitiveness of manufacturers.
This article provides an overview of IVDR, explores the bottleneck problem in depth, and connects it with key concepts such as IVDR compliance, IVDR requirements, IVDR classification, Notified Body IVDR, and EUDAMED IVDR.
What is IVDR and Why Is It Important?
The IVDR (Regulation (EU) 2017/746) is a European Union regulation governing in vitro diagnostic medical devices. It officially became applicable on 26 May 2022.
Its main objectives are:
- To improve patient safety
- To enhance product quality and reliability
- To increase transparency through digital systems
However, the stricter requirements introduced by IVDR have also led to a major challenge known as the IVDR bottleneck, which is currently impacting the entire industry.
What is the IVDR Bottleneck?
The IVDR bottleneck refers to a situation where:
- A large number of products require certification
- But there are not enough assessment bodies (Notified Body IVDR) available
As a result:
- Certification processes are significantly delayed
- A backlog of submissions builds up
- Companies cannot place their products on the EU market on time
Root Causes of the IVDR Bottleneck
- Massive Increase in Products Requiring Notified Body Review
Under IVDR:
- Previously, only ~15% of IVDs required Notified Body review (IVDD era)
- Now, 80–90% of IVDs must go through a Notified Body
This has caused a sharp increase in demand for Notified Body IVDR services
- Stricter IVDR Requirements
IVDR requirements now cover the entire product lifecycle, including:
- Performance and clinical evidence
- Technical documentation
- Post-market surveillance (PMS)
This significantly increases the time required for each product assessment
- Limited Number of Notified Bodies
A Notified Body is responsible for evaluating devices and issuing CE certificates. The challenge is:
- Only a limited number of Notified Bodies are designated under IVDR
- Each has constrained capacity
This creates an unavoidable “bottleneck” in the system
- Complex IVDR Classification System
IVDR classifies devices into four risk categories:
- Class A (low risk)
- Class B
- Class C
- Class D (high risk)
Devices in Class B, C, and D must all be assessed by a Notified Body → This dramatically increases workload
The Role of EUDAMED IVDR
EUDAMED IVDR is the EU’s central database used for:
- Registering manufacturers (e.g., manufacturers, importers)
- Registering products (UDI)
- Reporting incidents and post-market surveillance activities
While it improves transparency, the system is still being gradually implemented.
This has added complexity and contributed to delays in certain processes
Impact of the IVDR Bottleneck
- Delayed Market Access
New products must wait longer for approval, resulting in lost business opportunities.
- Device Shortages
Some companies choose to:
- Discontinue certain products
- Focus only on high-profit items
- Increased Costs
Costs rise in areas such as:
- Regulatory consulting
- Testing and clinical evidence generation
- Quality system implementation
- Slower Innovation
Companies delay launching new products due to high regulatory burden.
How to Address the IVDR Bottleneck
To achieve effective IVDR compliance, organizations should:
- Prepare Technical Documentation Early
Align documentation with IVDR requirements from the early development stage
- Develop Strategy Based on IVDR Classification
Prioritize critical products (higher class = higher risk)
- Engage Notified Body IVDR Early
Reduce the risk of long queues
- Use EUDAMED IVDR Properly
Ensure readiness of data and UDI submissions
- Plan Long-Term Transition Strategy
Especially for legacy devices
Conclusion
The IVDR bottleneck is not just a temporary issue - it is a structural challenge within the regulatory system.
It is driven by:
- Increased workload (IVDR classification + new requirements)
- Limited resources (Notified Body IVDR)
- New digital systems (EUDAMED IVDR)
Organizations aiming to succeed in the EU market must develop a deep understanding of both IVDR compliance and IVDR requirements, and adopt a proactive, strategic approach rather than a reactive one.
For professionals working in QA/RA or auditing, the IVDR bottleneck is one of the most critical risks that must be continuously monitored.
About SGS
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