The Notified Bodies Speak: What Team-NB Says About the Proposed EU MDR Reform
The EU MDR reform is advancing, and someone has finally decided to say what many have been thinking quietly. On April 8, 2026, Team-NB, the European Association of Notified Bodies, published its official position in the public consultation on the planned MDR/IVDR amendments. Their paper is not dry bureaucracy. It's a serious warning and, in some parts, a documentation of a retreat from a regulation that was painstakingly constructed.
If you are a medical device manufacturer, a regulatory consultant, or simply following the changes in the EU MDR, you should definitely know what is being said here.
Background: What is the "Targeted Revision" Anyway?
The European Commission has initiated a Targeted Revision process for the MDR and IVDR. The stated goal: reduce bureaucratic burden, remove barriers to market entry for devices in the European market, and help SMEs cope with the requirements. After years of criticism that the MDR created severe bottlenecks, delayed essential devices, and harmed small notified bodies, it is clear that something must be done.
But, as always in regulation, the question is not just what is being changed. The question is how, and at what cost.
What Team-NB Says: The Big Picture
Team-NB opens with clear support for the principles of the regulation and the goal of protecting public health. But then comes the fundamental reservation:
The proposed amendment creates a cumulative and systematic reduction of preventative oversight measures.
This is not a criticism of a single clause. It is an argument that the entirety of the proposed changes, even if each one seems reasonable on its own, collectively creates a worrying picture.
What Specifically Reduces Oversight?
According to Team-NB, the problematic changes include:
Reduction of Notified Body involvement in certification and surveillance activities
Reduction of sampling and surveillance audits (sampling audits, surveillance audits)
Reduction of SS(C)Ps and PSURs (Summary of Safety and (Clinical) Performance and Periodic Safety Update Reports)
Removal of expiry dates for certificates and a change to the Recertification mechanism
Reduction of transparency obligations
Team-NB's claim: In summary, this move lowers oversight below the level that existed under the old Directives (AIMDD, MDD, IVDD). In other words, not only are we not moving forward, but we are going backwards.
A Point You Need to Know: 0.28%
One of the sharpest claims in the paper:
The current oversight system represents only 0.28% of the medical device sector's turnover in Europe.
In other words, the proposed reduction will not generate significant savings. The cost of oversight is small relative to the entire sector. But the risk it creates is not small at all.
This is a sharp economic argument: if you want to save, you're not saving much. And if you are risking public safety to save less than 0.3%, it provides an important perspective on the balance.
Performance-Based Oversight Model: The Counter-Offer
Team-NB doesn't just criticize. It proposes an interesting alternative: a Performance-Based Oversight model.
The idea: reducing oversight should not be a "default" for all manufacturers. It should be a reward earned over time.
According to the proposed model:
A manufacturer who has accumulated successful compliance cycles, with no major and open non-conformities
Who has demonstrated high performance over time
Who has no open safety incidents against them
Only then, and in a time-limited and reversible manner, can reduced oversight be considered.
This is a fundamental change from the proposed approach. In the Commission's approach: everyone gets a break. In Team-NB's approach: those who have earned it get it, and those who haven't—don't.
The OEM Problem: Something That Could Shatter the Liability Structure
One of the most important technical points for manufacturers and consultants: amendments to Article 10(9)(f)-(g).
The proposal re-enables OEM-type manufacturing arrangements where a manufacturer bears full legal responsibility for compliance, but may not have access to the technical documentation required to prove that compliance.
Such a structure is a recipe for disaster. On one hand, a company holds a CE Certificate. On the other hand, the information needed to prove compliance is held by the OEM. It has no control and no access. But it is responsible.
Team-NB simply calls this: "unacceptable liability and regulatory risks".
Deletion of Article 10(16): The "Anchor" Proposed for Removal
Another sharp criticism: the proposal to delete Article 10(16) of the MDR.
This article explicitly states that the manufacturer is the primary party responsible for the device's compliance and must hold appropriate insurance. This sounds basic, but its power lies in the fact that it defines the legal liability structure clearly for everyone: patients, authorities, and the regulatory system as a whole.
Deleting it would remove a clear anchor point of legal certainty. Team-NB unequivocally opposes this proposal.
Definitions, Ambiguity, and the WET List
Team-NB also makes a general request for greater legal clarity. Specific points raised include:
Sources of clinical data: Clarification is needed regarding acceptable sources and limitations on the use of non-clinical data
Well-Established Technologies (WET): The Commission recently published an updated list. Team-NB supports a binding list with a clear and limited legal definition, to be maintained through Implementing Acts. The list should not be used as a justification for easing oversight on higher-risk devices
Definition of equivalence for IVDs: A clear definition is required, which is still lacking
Computer modeling and in-silico testing for IVDs: A clear framework is needed for validating IVD operations where performance metrics are derived from computerized experiments
EUDAMED: Access Not Currently Granted
Team-NB expresses support for EUDAMED but also demands something simple: that Notified Bodies be given direct and comprehensive access to the database.
Currently, according to the paper, such access is not sufficiently available. And this is problematic, because the legal responsibility of Notified Bodies under Articles 83-86 and Annexes III and IX is not dependent on requesting permission. They need information to perform effective oversight.
Without such access, assessors cannot perform preventative oversight. This thwarts the very stated goal of the regulation.
Bureaucratic Burden: Notified Bodies Are SMEs Too
A point that directly relates to the discussion on SMEs: some Notified Bodies are also SMEs.
Therefore, when the Commission proposes to increase the frequency of Joint Assessments to every two years (instead of every three), it adds a burden on bodies that are already overloaded. Team-NB argues that an audit every two years for Notified Bodies is more stringent than the oversight that will be applied to manufacturers themselves under the revised proposal. Those who are supposed to supervise will be subject to more frequent audits than those they supervise, and therefore it is neither fair nor proportionate.
Their position: the current schedules for Joint Assessments should be maintained.
What Does This Mean in Practice for Manufacturers and Regulatory Consultants?
The Team-NB paper is not just internal European politics. It has direct implications.
If the changes are approved as proposed:
There will be increased uncertainty about what constitutes "sufficient compliance"
Some manufacturers will face a looser liability structure (e.g., the OEM problem) that could turn out to be a trap
Transparency will decrease, making it harder to assess competitors and prioritize oversight
If Team-NB's position is accepted:
A broader oversight framework will be maintained, but with performance-based flexibility
Manufacturers with a good track record will be able to earn tangible reliefs
There will be more legal and operational certainty
A Perspective: What Do We Choose?
The MDR in its current form is not working well enough. Timelines are long, Notified Bodies are overloaded, and essential devices are failing to reach the market. These are real problems that need a solution.
But the solution cannot be to simply remove oversight. The solution is to make oversight work better, be smarter, and reward manufacturers who invest in safety and long-term compliance.
Team-NB presents such an approach. One can disagree with them on specific points, but their central logic is correct: less-informed oversight is not less oversight. It is oversight that fails before something happens.
Right now, the process is still open. The positions of the Notified Bodies, the MDCG, and the responses from manufacturers and users will all influence the final version. Therefore, if you are following the EU MDR, now is exactly the time to keep a close watch.