Selection, Capacity, and Strategic Impact on Medical Device Approval
Years into the EU Medical Device Regulation (MDR), properly planning for notified body involvement remains essential, as their role continues to be one of the most significant determinants of CE-marking timelines.
For many manufacturers, delays under MDR are often not driven by product readiness, technical documentation quality, or even clinical evidence but by notified body availability, scope limitations, and review capacity. As a result, notified body strategy has evolved from a procedural requirement into a core element of regulatory planning.
Early, informed engagement with the right notified body can mean the difference between predictable market access and multi-year delays. Under MDR, notified bodies are no longer interchangeable. Selection, timing, and relationship management directly influence approval timelines and regulatory risk.
What Is a Notified Body?
What does a notified body do under EU MDR?
A notified body is an independent organization designated by an EU Member State to assess medical devices for conformity with MDR requirements before CE marking.
Under MDR, notified bodies are responsible for:
- Conducting conformity assessments
- Auditing quality management systems
- Reviewing technical documentation
- Assessing clinical evaluation and post-market plans
- Performing ongoing surveillance after certification
Compared to the Medical Device Directive (MDD), what does a notified body do under EU MDR? It has significantly expanded notified body responsibilities. Expectations are more rigorous, documentation reviews are deeper, and clinical evidence scrutiny is substantially higher. This shift has increased both review duration and variability in interpretation.
Current Notified Body Landscape
The MDR notified body ecosystem is defined by scarcity and specialization.
Designation Status and Scope Limitations
While the number of MDR-designated notified bodies has increased since 2021, designation scope varies widely. Many bodies are approved only for specific device codes, technologies, or risk classes. A notified body designated under MDR may still be unable to review certain Class IIb or Class III devices.
Capacity Challenges and Long Review Timelines
Demand continues to outpace capacity. Manufacturers routinely experience:
- Extended wait times just to secure a contract
- Long gaps between submission and review
- Limited availability for follow-up questions or remediation reviews
Variability in Expertise
Notified bodies differ in technical depth by device category. Experience with legacy devices does not always translate to expertise in novel technologies, software, or combination products.
Notified Body Scope and Capacity Comparison (Example)
| Factor | Impact on Manufacturers |
|---|---|
| Designation Scope | Determines eligibility to assess your device |
| Device Class Coverage | High-risk devices face greater constraints |
| Technical Expertise | Affects quality and consistency of feedback |
| Review Capacity | Directly influences approval timelines |
| Geographic Location | Impacts communication and audit logistics |
How to Select the Right Notified Body
How do manufacturers choose the right notified body for their device?
Selection should be based on strategic alignment, not availability alone.
Scope Alignment
Confirm that the notified body’s MDR designation fully covers your device classification, intended use, and applicable codes. Partial alignment can lead to mid-review transfers or rejection.
Experience With Similar Technologies
Look for demonstrated experience with comparable devices, particularly for software, digital health, and novel technologies where interpretation risk is higher.
Geographic and Language Considerations
Audit logistics, time zones, and working language can materially affect communication efficiency and responsiveness.
Transparency and Review Approach
Notified bodies vary in how they communicate expectations, handle questions, and manage review cycles. Clarity and consistency are critical under MDR.
Timing and Engagement Strategy
How early should manufacturers engage a notified body? Earlier than most expect.
Manufacturers should begin engagement 12–18 months before intended submission, especially for higher-risk devices.
Early engagement enables:
- Confirmation of scope and eligibility
- Alignment on conformity assessment route
- Identification of documentation or evidence gaps
- Planning for QMS audits and readiness reviews
Pre-submission interactions, while limited, help align technical documentation with notified body expectations and reduce avoidable nonconformities.
Common Challenges and Risk Areas
Even experienced manufacturers face recurring challenges under MDR:
- Delayed conformity assessments due to capacity constraints
- Inconsistent MDR interpretation between notified bodies
- Limited availability for Class III and implantable devices
- Unexpected remediation cycles driven by clinical evidence expectations
Without proactive planning, these issues can cascade into significant commercial delays.
Managing Notified Body Relationships
Notified body engagement does not end with certification.
Ongoing responsibilities include:
- Managing significant change notifications
- Preparing for surveillance audits
- Addressing nonconformities efficiently
- Planning renewals and scope expansions
Manufacturers transitioning from MDD certificates must also manage legacy timelines while aligning with MDR surveillance expectations.
Strong relationship management, supported by documentation discipline and timely communication, reduces friction across the certification lifecycle.
How Technology Supports Notified Body Readiness
Technology plays an increasingly important role in mitigating MDR complexity.
Key capabilities include:
- Document version control and traceability across technical files
- Audit readiness and gap analysis aligned to MDR annexes
- Centralized communication records for notified body interactions
- Evidence management linking clinical, risk, and post-market data
Digital readiness enables faster responses, clearer audits, and reduced remediation cycles, critical advantages in a constrained notified body environment.
Conclusion
Under EU MDR, notified body strategy is no longer an administrative detail, it is a determinant of regulatory success.
Manufacturers that proactively assess scope, engage early, and plan for capacity limitations are better positioned to achieve predictable CE marking timelines. Long-term planning, supported by data and technology, is essential to reducing regulatory risk in an evolving MDR landscape.
Q&A
What does a notified body do under EU MDR?
A notified body assesses medical devices for conformity with MDR requirements, including QMS audits, technical documentation review, and ongoing surveillance.
How do manufacturers choose the right notified body for their device?
By aligning notified body designation scope, device expertise, capacity, and communication approach with their specific product and risk class.
Why are notified body timelines a major risk under MDR?
Limited capacity, high demand, and expanded MDR requirements lead to long wait times and extended review cycles.
How early should manufacturers engage a notified body?
Ideally 12–18 months before submission, especially for Class IIb and Class III devices.
