In 2025, TEAM-NB, the European Association of Notified Bodies (NBs), released its revised Code of Conduct (Version 5.1). Just weeks earlier, the European Commission published the 12th Notified Body Survey, offering a detailed statistical overview of the MDR certification landscape.
When read together, these two documents offer more than complementary views; they reveal a tension between objectives and operational realities. By bridging the survey data and the Code of Conduct, we can better understand the current state of MDR implementation and where its most urgent recalibrations lie.
A Pledge for Excellence: The Aspirational Role of TEAM-NB
The new Code of Conduct opens with a clear statement to “work on continuing harmonisation between NBs”.
The principles enshrined are sound: impartiality, transparency, consistency. The Code emphasizes that NBs should apply MDR and IVDR in a fair and harmonized way, avoid conflicts of interest, and ensure quality of service and communication with manufacturers.
On paper, this is reassuring. But does the practice match the principles? The data from the Notified Body Survey, if read closely, suggests that this alignment remains aspirational rather than actual. For example, the Well-Established Technology (WET) approach is currently not handled consistently between Notified Bodies and would need alignment through a TEAM-NB position paper.
It should be noted that Team-NB is a voluntary organization, and not all Notified Bodies are members. Team-NB has 42 members, representing approximately 82% of all designated Notified Bodies under the MDR and IVDR. This means that adherence to the Team-NB Code of Conduct is not universal. Even among members, the Code is implemented on a voluntary basis and is not legally binding.
Refusals Due to “Out-of-Scope”: An Avoidable Failure of Communication
The leading reason for application refusal remains:
“Scope outside NB designation”, cited by 54% of NBs.
This is a noteworthy statistic. In a system governed by public transparency tools such as the NANDO database, where each NB’s designation scope is clearly listed by MDR codes (MDA, MDN, MDS, MDT), such mismatches should be avoidable–yet they persist. If over half of NBs cite “out of scope” as a refusal reason, there appears to be a misalignment with the clear information objective to be provided to manufacturers according to the TEAM-NB code of conduct, either in how NBs communicate their scope or in how manufacturers are expected to interpret and apply that scope. This issue is not merely technical; it may impact efficiency and extend timelines on the maturity of the system.
The “Other” Reasons for Refusal: A Mirror of Fragmented Application
The survey’s list of secondary refusal reasons reads like an indication of areas needing better alignment:
- Withdrawal by customer
- Concerns over Article 7 violations
- Misclassification
- Cessation of communication
- Refusal of audits
- Language non-compliance
- Unresolved non-conformities
Together, these account for over 20% of refusals.
This raises two questions:
- Are manufacturers fundamentally underprepared?
OR
- Are NBs inconsistent in interpreting and applying expectations?
According to the Code of Conduct:
“All Signatories are committed to find ways of implementation and enforcement that are effective, transparent and will lead to structural harmonisation and securing of the quality level of NBs. Complaints related to not following the CoC will result in an investigation by TEAM-NB.”
Interpretations of Article 7 (misleading claims), classification rules including the Well-Established Technology (WET) status, and language requirements differ across NBs; this harmonization is still in progress. For language requirements, most Notified Bodies can work in English, but when other languages are required, there is not only the requirement for Notified Bodies to have personnel technically competent in the relevant medical device area, but also to be fully competent in the area of medical nomenclature in the relevant language. Most Notified Bodies will indicate in their application forms which languages they can accept, so manufacturers should check this area before submitting documentation.
Moreover, the commitment to effective communication, repeatedly emphasized in the Code, may be challenged by the simple fact that “client stopped communication” is a recurring refusal reason. In a well-functioning system, such drop-offs should be rare, not frequent. The new Structured Dialogue process should help manufacturers in this way whose “aim was to enhance the efficiency and predictability of conformity assessment”.
Certification Timelines: An Ethical Issue, Not Just Operational
Per the survey:
- 81% of NBs report 13–24 months for QMS+Product certification (stage 1 and 2)
- 52% report 13–18 months for QMS alone (stage 1)
The Code of Conduct states:
“NBs need to be motivated to adapt rapidly to the ever-changing technological needs, hiring sufficient competent staff and help make new technologies quickly available to patients through efficient and robust approval processes.”
The Code’s timeline table can also be confusing for manufacturers as the review timeline is indicated as up to 18 days, but this time is only for the first round of questions, and these are not necessarily consecutive days but separated by weeks, potentially in the internal NBs review process.
Here lies a potential area for improvement: while most NBs are making evident efforts, the reality is that the median certification timeline exceeds the life cycle of many MedTech innovations. Worse, only 8% of NBs report that the submitted Technical Documentation was compliant for review at the pre-audit stage, a claim that highlights the need for clarification and support for manufacturers at the earliest stage of the Technical Documentation preparation. The result is a system consumed by iteration, re-review, and document correction–not validation.
When delays become the norm, patient access to essential medical devices is compromised, raising both technical and ethical considerations. Furthermore, small and medium-sized enterprises (SMEs) are disproportionately affected by the regulatory burden, with many devices failing to complete the MDR transition and, in some cases, companies being forced to shut down entirely.
Volume vs. Capacity: The Regulation as Bottleneck
- 28,579 MDR applications submitted
- 10,554 certificates issued (~37%)
Among these:
- ~3,500 were first-time Product Certificates
- ~4,000 were first-time QMS Certificates
This implies a persistent backlog. Despite improvements in NB capacity (e.g., 2,196 qualified staff reported), the system continues to process fewer certificates than needed, with many applications taking over a year to complete.
The Code’s call for ensuring harmonized quality while maintaining efficiency remains a goal, but not yet reality.
SMEs and Proportionality: A Growing Disparity
Survey data confirm that more than 90% of NBs serve predominantly SMEs. Despite this, MDR compliance demands for clinical evidence, PMS plans, and EUDAMED readiness are structurally better suited to large corporations.
Despite the Code’s pledge:
“It is intended that this will lead to consistency of audit duration and TD assessment duration between NBs, as well as between similar clients of the same NB.”
SMEs are clearly under pressure. Without regulatory support or scalable pathways, many innovators risk regulatory attrition, exiting the EU market or delaying submissions due to resource limitations. This undermines Europe’s strategic autonomy in MedTech innovation and disproportionately benefits better-resourced global actors.
Ethical Oversight vs. Operational Ground Truth
The Code of Conduct introduces important clauses on impartiality, complaint handling, and internal training. These include:
- Declarations of conflict of interest
- Establishment of escalation mechanisms
- Training to ensure MDR/IVDR application is up to date and consistent
These are essential pillars for long-term trust in the NB system.
However, the survey reveals areas still suffering from a lack of harmonized implementation, such as:
- Annex XVI devices: Largely untouched (23 NBs report 0 certificates)
- Reprocessing single-use devics (Art.17): No certifications issued so far while 20 NB have it in their designation scope
- Article 117 opinions for drug-device combination products: 370 requests vs. ~265 actual opinions delivered
This suggests areas of regulatory uncertainty. Parts of MDR remain under-utilized due to a lack of NB readiness or interpretative clarity. In practice, this may delay innovation while safety benefits are still being evaluated.
Strategic Outlook: Alignment Through Action
For TEAM-NB and the wider ecosystem, the way forward is clear. The values outlined in the Code of Conduct must be translated into tangible practice across four dimensions:
- Scope clarity and pre-engagement transparency
- Prevent “out-of-scope” rejections through structured pre-submission alignment and clearer NB mapping.
- Timeliness and capacity
- Expand NB capacity, reduce rework, and provide better triage to prioritize time-sensitive applications.
- Support for SMEs
- Develop scalable engagement models, including collaborative pre-submission reviews or tiered documentation templates.
- Consistency across Article 7, classification, Well-Established Technology (WET) and Annex XVI
- Promote interpretative alignment through joint MDCG/NB workshops and harmonized guidance enforcement.
Structured Dialogue: A Promising Bridge, Still Under Construction
In parallel with the latest developments from the Notified Bodies and the publication of TEAM-NB’s revised Code of Conduct, a new mechanism is quietly reshaping NB-manufacturer engagement in Europe–the Structured Dialogue process under the MDR.
Inspired by the US FDA’s Q-Sub program, which allows early, non-binding, structured interactions between applicants and regulators, this new European initiative represents a long-awaited evolution in how dialogue is managed throughout the conformity assessment lifecycle.
At its core, the Structured Dialogue process aims to:
- Foster early communication between manufacturers and NBs
- Identify key issues around classification, clinical strategy, or technical documentation before formal submission
- Streamline expectations to reduce post-submission delays
On principle, this is a welcome development. For years, the lack of a formal European equivalent to the FDA’s pre-submission process has been cited as a major source of unpredictability, contributing to excessive timelines and unnecessary refusals.
However, several structural risks must be acknowledged.
1. Blurred boundaries: guidance vs. consultancy
According to both the MDR and the Team NB Code of Conduct, Notified Bodies “shall not offer or provide consultancy services to the manufacturer, its authorized representative, a supplier or a commercial competitor” (MDR Annex VII 1.2.3(d)).
The Structured Dialogue process tests this boundary.
During calls or pre-submission discussions, manufacturers often seek clarity on technical, clinical, or classification strategies, and NBs, seeking to be helpful or to reduce future delays, may be tempted to give proactive advice. But when does clarifying expectations cross into consultancy?
The lack of harmonized interpretation among the 51 designated NBs only amplifies this ambiguity. Some NBs are pragmatic and open to dialogue, while others remain rigidly reserved, offering minimal input to avoid regulatory overreach. The result is inconsistency, confusion, and regulatory risk for both parties, even when considering that Team-NB is a voluntary organization and not all Notified Bodies are members.
2. Disparities between NBs
The Structured Dialogue process is not uniformly implemented across all NBs. Some NBs offer formal engagement protocols, standard templates for questions, and scheduled meetings with multidisciplinary panels. Others provide ad hoc calls or informal email exchanges with no clear procedural guidance or scope limits.
This creates a variation in regulatory experience, the manufacturer’s experience, and the resulting impact on submission strategy may vary significantly depending on the NB selected. This divergence runs counter to the stated objective in the Team NB Code of Conduct to promote a harmonized approach.
Until this process is formalized at EU level, ideally through MDCG guidance or a harmonized TEAM-NB detailed framework, manufacturers remain exposed to uncertainty in both process and outcome.
3. Procedural vs. substantive outcomes
While the initiative echoes the FDA Q-Sub model, its legal and procedural implications differ:
- FDA Q-Subs are documented, logged, and benefit from agency-wide guidance outlining timelines, permissible content, and regulatory implications.
- EU Structured Dialogues, by contrast, are non-binding, may not be fully documented, and currently lack standardization of scope or follow-up.
This creates a paradox: manufacturers may rely on verbal or informal feedback during the call but cannot cite or validate it later if the NB’s position changes during the conformity assessment. This lack of traceability not only introduces risk, but may also disincentivize manufacturers from trusting the feedback, reducing the utility of a process intended to build confidence and alignment.
Conclusion: From Dialogue to Coherence
The MDR landscape is maturing, but unevenly. The 12th Notified Body Survey and the new TEAM-NB Code of Conduct both demonstrate a system striving for alignment, ethics, and efficiency. The introduction of Structured Dialogue is a promising development, one that introduces a form of strategic pre-engagement long needed in Europe.
However, coherence between principle and practice remains the challenge:
- Refusals due to designation mismatch should not exist in an age of NANDO transparency
- Time-to-certification must be addressed as an ethical imperative, not just a bureaucratic hurdle
- Dialogue with NBs should be structured, documented, and equitably applied
Addressing these elements can help MDR reach its full potential.
NAMSA: Strategic Partner for MDR Success
At NAMSA, our Regulatory team works daily with manufacturers to bridge this very gap, from intention to execution. We provide:
- NB mapping and scope alignment using real-time NANDO expertise
- Clinical and regulatory strategy to prevent pitfalls and improve time-to-market
- Technical documentation planning to ensure readiness and completeness
- Accelerated NB engagement support, including pre-assessment and Structured Dialogue preparation
- Dedicated SME pathways, balancing compliance with feasibility
Our goal is to make MDR achievable, not overwhelming, and to ensure that innovation is not the collateral damage of regulatory evolution.
