Since the entry into application of the European Medical Device Regulation (MDR – Regulation (EU) 2017/745) in May 2021, regulatory requirements for medical devices have significantly increased across Europe.
The objective is clear: improve patient safety, strengthen the traceability of medical devices and enhance the quality of clinical evidence.
However, several stakeholders in the sector are now raising concerns about an unexpected risk: the shortage of medical devices. In certain areas — including orthopedic implants, pediatric devices or niche technologies — access to some solutions could become more limited.
This raises an important question: is the MDR contributing to a shortage of medical devices in Europe?
Shortage of medical devices: is it linked to stricter regulatory requirements?
The MDR has profoundly transformed the regulatory framework for medical devices, with the risk to involve shortage of medical devices. It notably introduces:
- more robust clinical evaluation requirements,
- stronger post-market surveillance obligations,
- enhanced traceability through the UDI system,
- and stricter oversight from notified bodies.
These changes reflect the European Union’s intention to strengthen patient protection following several health scandals.
The regulation defines a medical device as any instrument, apparatus or software intended for medical purposes whose principal mode of action is not pharmacological, immunological or metabolic.
According to the European Commission, these new requirements aim to improve the quality of clinical evidence and increase transparency in the health technology market.
https://health.ec.europa.eu/medical-devices-sector/new-regulations_en
Why the MDR could contribute to a shortage of medical devices
Despite these legitimate objectives, several MDR-related factors could contribute to a shortage of medical devices in Europe.
1. A limited number of notified bodies
One of the main bottlenecks concerns the capacity of notified bodies to assess MDR certification files.
Their number remains relatively limited in Europe, while thousands of devices must be recertified before the end of the transition period.
According to the European industry association MedTech Europe, this regulatory bottleneck could delay market access for many technologies and potentially contribute to a shortage of medical devices.
https://www.medtecheurope.org
2. Rising regulatory costs
The MDR also requires:
- more extensive clinical data,
- more frequent clinical investigations,
- and significantly more detailed technical documentation.
For some SMEs or manufacturers of low-volume devices, these requirements can become disproportionate from an economic perspective.
As a result, some manufacturers may choose to withdraw certain devices from the European market, which can increase the risk of a shortage of medical devices.
3. Niche medical devices particularly at risk
Technologies intended for smaller patient populations are especially vulnerable to this situation, including:
- pediatric medical devices,
- specialized implantable technologies,
- devices used in rare indications.
In such cases, the cost of MDR recertification may exceed the economic viability of the product, increasing the likelihood of a shortage of medical devices in specific therapeutic areas.
Several analyses in the scientific literature highlight this risk, particularly in fields such as orthopedics and implantable technologies.
The European Union seeks to prevent shortages
In response to growing concerns from healthcare professionals and manufacturers, the European Union has already taken several measures.
In 2023, the European Commission adopted a regulation extending the MDR transition timelines, precisely to avoid large-scale device withdrawals and the potential shortage of medical devices in Europe.
This extension aims to:
- give manufacturers more time to obtain MDR certification,
- prevent a shortage of critical medical devices,
- and maintain continuity of patient care.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607
Finding the balance between safety and access to medical devices
Strengthening the European regulatory framework responds to a legitimate objective: ensuring the safety and clinical performance of medical devices.
However, the implementation of the MDR reveals a structural challenge:
how can regulators reconcile high regulatory standards with sustainable access to health technologies?
For European authorities, the challenge is now to preserve safety objectives while preventing a shortage of medical devices that could affect both patients and healthcare professionals.
The debate remains open, and several regulatory adjustments are already under discussion.
One thing is certain: the MDR represents a major transformation of the medical device market in Europe, and its effects will continue to shape access to medical technologies in the coming years.
The European Union seeks to prevent shortages
In response to growing concerns from healthcare professionals and manufacturers, the European Union has already taken several measures.
In 2023, the European Commission adopted a regulation extending the MDR transition timelines, precisely to avoid large-scale device withdrawals and the potential shortage of medical devices in Europe.
This extension aims to:
- give manufacturers more time to obtain MDR certification,
- prevent a shortage of critical medical devices,
- and maintain continuity of patient care.
https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32023R0607
