One of the most fundamental differences between the EU and other regulatory systems is the role of the Notified Body (NB). While the FDA and NMPA act as centralized government authorities that directly approve medical devices, the EU relies on independent third-party organizations designated by EU Member States within a defined scope. The list of NBs can be found in the NANDO database.
In this blog, we explain how the Notified Body process works and what non-EU manufacturers need to consider to avoid delays and misalignment.
What the Notified Body Does
Notified Bodies (NBs) are responsible for:
- Interpreting MDR requirements within their designated scope
- Assessing whether the manufacturer's evidence demonstrates safety, performance, and an acceptable benefit–risk profile
- Evaluating the coherence of technical documentation, clinical data, and regulatory strategy
- Conducting conformity assessments for most medical devices (except certain Class I devices)
- Performing periodic and unannounced audits
- Issuing CE certificates prior to market access
- Conducting ongoing surveillance after certification
Because of this broad mandate, the relationship with the NB extends across the entire lifecycle of the device. This is not a one-time review, but an ongoing partnership that directly impacts the ability to maintain market access.
Selecting the Right Notified Body
Selecting an appropriate NB is a critical early step. The chosen NB must cover both the scope of the product portfolio and the Quality Management System (QMS). The selection process can be lengthy and should be initiated in parallel with product development and QMS implementation.
Early engagement allows manufacturers to clarify expectations, align on documentation requirements and templates, and identify potential gaps before formal submission.
Review Timelines: No Guaranteed Deadlines
Unlike the FDA, NBs do not operate under legally defined review timelines. CE marking timelines depend on multiple factors, including:
- The quality, structure, and clarity of the submitted documentation
- The completeness of the GSPR checklist
- The availability and capacity of NB experts
- The type and complexity of the device
- Internal NB processes
- The need for additional audits (e.g. sterilization, microbiology)
Once the formal review begins, assessment of technical documentation typically takes between 6 and 24 months. The more complete and coherent the submission, the more predictable the timeline.
Common Challenges That Cause Delays
Late engagement with an NB or misaligned submissions frequently lead to extended review cycles, additional information requests, and delays driven by limited NB capacity.
In more complex cases, this may result in:
- Restrictions on intended use or patient population
- Requirements for additional PMCF or clinical investigations
- Shortened certificate duration
- Rejection of the application
These outcomes are often linked to incomplete submissions or insufficient clinical evidence.
From Approval to Ongoing Partnership
Engaging with a Notified Body is not a one-time milestone, but a continuous process that requires alignment, preparation, and proactive management.
Engage your NB early, ensure your documentation is complete and coherent, and treat the relationship as a strategic priority from the outset.
Looking to Go Deeper?
Understanding the Notified Body process is only one part of achieving EU readiness. Many of the challenges discussed here, from documentation gaps to lifecycle alignment, are explored in more detail in our whitepaper.
Download the QbD Group whitepaper "Home Market Approval ≠ EU Readiness." to explore the key gaps and how to address them.
关于作者
PhD Physics, MSc Medical Physics · Business Unit Manager RA MD
Anne-Sophie is a Regulatory Affairs leader with over two decades of experience in medical physics, diagnostic imaging, and medical device regulation. She supports clients navigating EU MDR, FDA, and international regulatory frameworks.
关于作者
Business Unit Manager Medical Affairs
12 years of experience in the medical device field. Expert in clinical evidence and medical writing for Class I to Class III devices, including MDSW and AI-driven MDSW, as well as safety management in clinical investigations.
Watch the Webinar: Entering the European MedTech Market
Why one approval doesn't fit all — discover where FDA and NMPA logic breaks down under EU MDR, and how to build a defensible market-entry strategy.
Watch the webinar订阅生命科学领域的最新动态
专家观点直达您的收件箱——选择您的兴趣。
绝无垃圾邮件。随时取消订阅。
