Jun 23, 2023 2 min read

Regulating Health: The Impact of the European Medical Device Regulation on Medical Device Availability

The MDR increases medical device safety but also approval times and costs. Despite challenges, it's promoting higher industry standards and adaptability.

Regulating Health: The Impact of the European Medical Device Regulation on Medical Device Availability
Photo by Christian Lue on Unsplash
Deciphering the Effects of Regulation (EU) 2017/745 on Medical Device Accessibility

Navigating the terrain of health regulations may seem daunting, but I invite you to join me as we explore the European Medical Device Regulation (MDR) and its effects on the availability of medical devices.

The What: Understanding MDR

The MDR, or Regulation (EU) 2017/745, is a regulation by the European Union that came into full effect in May 2021. It's intended to ensure that medical devices, from bandages to pacemakers, meet the standards of safety, performance, and clinical efficacy.

The Why: MDR's Impact on Medical Device Availability

While its intentions are clearly aimed at patient safety, the MDR's impact on the availability of medical devices has been significant. Let's delve into the specifics.

Firstly, MDR demands rigorous clinical evaluations and quality checks. While this is undeniably beneficial for enhancing product safety, it has also led to longer approval times for new devices. As a result, potentially lifesaving innovations may take longer to reach those in need.

Secondly, the stricter regulations have led to higher costs for manufacturers, with small and medium-sized companies particularly affected. This could potentially limit the diversity and availability of devices on the market, as smaller firms struggle to meet the new requirements.

The How: Navigating the Regulatory Waters

It's crucial to understand that the transition to the new MDR wasn't expected to be smooth sailing. It's a transformative period for manufacturers, regulators, and healthcare professionals alike. However, the end goal is clear and noble: improving patient safety and ensuring that only high-quality medical devices reach our homes and hospitals.

At the same time, it's important to remember that regulations aren't static. As we learn from the implementation of the MDR, adjustments and adaptations can be made to ensure a balance between safety and accessibility.

The Future: Inspiring Change and Adaption

While the MDR has undoubtedly caused ripples in the medical device market, it's also sparked inspiration for change and adaption. Many companies are rising to the challenge, investing in rigorous testing and quality assurance to meet the new regulations. It's a testament to the resilience and dedication of those working behind the scenes in the medical device industry.

The implementation of the MDR is an ongoing journey, and we're all learning and adapting as we go. It's my hope that we'll continue to balance patient safety with the need for innovative and accessible medical devices.

Let's keep the conversation going. What are your thoughts on the MDR? How do you think it will shape the future of healthcare?

Torsten Kneuss
An engineer living near Berlin, pharmaceutical professional and an expert in the fields of medical devices, combination products, and pharmaceutical packaging.
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