The Disappointment of the MDR
Some time ago, Szymon Brzósko and Robert Mołdach published the article “When Co-Creation Harms: On the Dysfunction of Creating Public Value.” I read it with great interest – not only because the topic is important, but also because it brilliantly illustrates the mechanisms I see every day as a practitioner. My perspective, however, is different – I see all this through the eyes of a medical device manufacturer, and to make matters worse, a manufacturer operating from a so-called third country, namely the United Kingdom.
The European Union’s change of approach – the transition from the MDD and AIMDD directives to the MDR 2017/745 regulation – was intended to address the growing technological, social, and systemic challenges in healthcare. The main impetus was the need to improve patient safety, as patients increasingly use more complex, personalized medical devices, often classified as higher-risk.
For years, directives formed the foundation of the market, but they gave member states too much latitude in interpretation. The result? Inconsistency in oversight, conformity assessment, and product availability. In practice, this could pose a threat to patients – especially in the context of cross-border trade in devices.
The MDR was supposed to change this. It introduced direct applicability of regulations in all EU countries, without the need for transposition into national law. It sounded good – a uniform, more rigorous system, stricter clinical and technical requirements, expanded obligations for manufacturers, importers, and distributors, and a central EUDAMED database for greater transparency and oversight.
The introduction of the MDR was also a response to specific incidents – such as the PIP implant scandal – that demonstrated that the oversight system needed strengthening and public trust in medical devices needed to be restored.
The European Commission organized workshops, surveys, and working groups. Everything looked promising. The new regulation was supposed to address real market needs. But the reality after implementation proved brutal.
The MDR was supposed to be a shield – for patients, support for manufacturers, and a clear guide for everyone. It turned out differently.
As Brzósko and Mołdach brilliantly put it, the concept of “dis/value,” or the dysfunction or devaluation of co-creating public value, described by Eriksson, Williams, and Hellström in 2023, is gaining increasing importance. To understand its significance, it’s worth drawing on the public value framework of Mark H. Moore, a pioneer in public management. His model is based on the so-called strategic triangle: public value, legitimacy and support, and operational capabilities.
Public value is the core—it’s about real outcomes that matter to society: better health, equality, and access to services. Legitimization and support represent support from key stakeholders—politicians, citizens, and organizations. Operational capabilities represent the resources, competencies, and processes that enable these goals to be effectively achieved.
The Prose of Life
Okay – but how does this “co-creation dysfunction” translate into the everyday lives of medical device manufacturers? It does – and has for almost a decade. Unfortunately, not in a positive way.
The MDR was supposed to be a protective shield for patients and a convenience for manufacturers – it was supposed to organize regulations and provide clarity. Instead, it has become a barrier: for manufacturers, for notified bodies, for patients. Instead of protecting them, it has begun to limit the availability of medical devices. An urgent reform is needed to restore the balance between safety and accessibility – taking into account the voices of patients, SMEs, and experts.
Erik Vollebregt, a lawyer specializing in medical regulations, compared the MDR to “regulatory lasagna in a blender.” Aptly. The MDR overlaps with other EU regulations – from the GDPR to the AI Act – creating chaos, a procedural maze, and fragmentation that, instead of protecting patients, distances them from the products they need.
A report by the European Patients’ Forum (EPF) shows that 44% of patients have experienced shortages or recalls of medical devices – insulin pumps, cochlear implants, and respiratory therapy equipment. Patients complain about a lack of information, a lack of channels for reporting problems, and concerns about the quality of substitutes. The regulation, intended to improve safety, has led to a reduction in safety – through the loss of access to proven products.
According to the latest European Commission survey (NB Survey 14), there are 51 notified bodies in the EU, the average certification time is 13–18 months, and by mid-2025, only 25,034 MDR and IVDR certificates had been issued. The system is overloaded, lacking resources, and lacking consistent interpretations – all of which lead to uncertainty and delays.
Notified bodies, associated with Team-NB and NBCG-Med, not only diagnose problems but also propose specific solutions: the creation of a Medical Device Coordination Office (MDCO), special pathways for innovative and orphan devices, simplified requirements for low-risk devices, fixed deadlines, and predictable certification costs. This is the voice of practitioners – people who face the consequences of MDR every day.
Besides Eric Vollebregt’s opinion on MDR, a growing number of experts and industry institutions are saying bluntly: MDR 2017/745 is not working as intended.
In their 2025 review of the scientific literature, Olivia McDermott and Breda Kearney point out that the greatest challenge facing MDR lies in the clinical evaluation requirements – particularly for medium-risk devices. Their research shows that:
- 54% of manufacturers plan to withdraw their products from the EU market after their certificates expire.
- The launch of new, innovative products is being postponed outside the EU.
- The lack of clear guidelines on “sufficient clinical data” leads to interpretation chaos.
In a study published in Therapeutic Innovation & Regulatory Science, Elisabeth Oltmanns, Michael D’Agosto, and Folker Spitzenberger show that:
- 80% of manufacturers consider the MDR requirements too stringent and unclear.
- Notified bodies interpret the regulations differently – some accept non-clinical data, others require full studies.
- For medium-risk devices, the cost of generating new data may exceed the product’s market value, leading to its recall.
Medical companies also point to:
- Excessive burdens on SMEs.
- Overloaded notified bodies.
- Lack of proportionality – low-risk products are subject to almost the same requirements as high-risk ones.
- Threat to innovation – manufacturers refrain from implementing new technologies in the EU.
All these voices – from scientists, manufacturers, and notified bodies – show one thing: MDR has structural problems. It lacks clarity, predictability, and proportionality. And all of this translates into a risk of losing access to products for patients.
This isn’t just a technical issue. It’s a classic “disfunction of co-creating public value.” Regulation, intended to protect, has begun to restrict.
And at the end of this whole puzzle is the patient. A patient who won’t always be operated on by a surgical robot – but will always need a scalpel, scissors, gauze, and a bandage. And it’s precisely these basic resources that may be lacking.
My Perspective
My perspective – that of an MDR practitioner who “delivered” MDR certificates for one company and delivers more for another – is unequivocally negative. I agree with every voice I cited above. But I want to add another dimension: cost.
For every £1,000 we spend on MDR, my organization must sell £7,000 worth of products. And my budget doesn’t end with those 1,000 – costs are rising, and the market is changing. I’m increasingly considering presenting the board with a list of products that, in my opinion, don’t generate enough profit to justify updating the MDR documentation. And that means one thing: these products could potentially disappear from the market. Disappear from hospitals. Disappear from patients… somewhere in Europe.
Eight years after the MDR entered into force, even the European Commission has begun to recognize that the original vision of the regulation needs adjustment – hence the publications and editions of new MDCG documents and guidelines, which aim to streamline the system and adapt it to market realities.
And now the European Commission is tackling another piece of legislation – this time, biotechnology – the Biotech Act.
Sound familiar? Centralization, harmonization, new obligations, new forms, new definitions. And although I’m an optimist by nature, it’s hard for me to believe this time will be any different than last time. Everything points to biotechnology becoming the next area where the EU will attempt to implement a centralized regulatory approach – similar to the MDR. Unfortunately, it seems we are once again heading towards another dysfunctional act that, instead of fostering innovation, could disrupt the market – especially among SMEs and manufacturers of products with high potential but limited resources.
Sources
Vollebregt, E. (2023). MDR and IVDR: Regulatory lasagna in a blender. Axon Lawyers Blog.
Vollebregt, E. (2024). The EU MDR: What went wrong and how to fix it. Presentation at the RAPS Euro Convergence conference.
EPF (2024). Patient Perspectives on Implementation Challenges of the EU Medical Devices Regulations. European Patients’ Forum.
European Commission (2025). NB Survey 14 – Summary of Results. Directorate-General for Health and Food Safety.
Team-NB & NBCG-Med (2025). Notified Body Perspective on Future Governance in the EU Medical Device Sector. Team-NB.
Team-NB (2022). Best Practice Guidance for Technical Documentation under MDR 2017/745. Team-NB.
McDermott, O. & Kearney, B. (2025). A review of the literature on the new European Medical Device Regulations requirements for increased clinical evaluation. International Journal of Pharmaceutical and Healthcare Marketing.
Oltmanns, E., D’Agosto, M., & Spitzenberger, F. (2025). Appropriateness of Clinical Data Under Regulation (EU) 2017/745 – A Case Study and Survey. Therapeutic Innovation & Regulatory Science.
GB Pharma (2024). Compliance Insights: Understanding the Regulatory Landscape – the Impact of MDR 2017/745 on Medical Devices. GB Pharma Blog.
Brzosko, S. & Mołdach, R. (2025). When co-creation harms: on the “dysfunction” of public value creation. Agreement for Public Value.
New European biotech act. Which way forward? European Commission Briefing (2025).