Revamping Medical Regulations: A Call for Comprehensive Reform

By Danélia Botes

November 16, 2023

The Regulatory Hurdle

Europe’s healthcare system, known for its extensive social security and fair healthcare access, faces a test of strength. Structural barriers in the existing regulatory framework hinder the prompt distribution of vital medical technologies. These technologies are crucial at every patient care stage.

The In Vitro Diagnostic Medical Devices Regulation (IVDR) and Medical Devices Regulation (MDR) were designed with the objective of creating a robust, transparent, predictable, and sustainable regulatory system for medical devices. The expectation was that these regulations would foster innovation while ensuring high levels of safety and health. However, more than half a decade into their implementation, the IVDR and MDR have fallen short of achieving these goals. The result is a sluggish, unpredictable, costly, and intricate process.

The Call for Change

MedTech Europe, a prominent representative of the medical technology industry, advocates for a comprehensive overhaul of the regulations to make them more beneficial for patients and European health systems. This reform should focus on three main areas: efficiency, innovation, and governance.

Efficiency: MedTech Europe suggests a more streamlined and cost-effective CE marking system. This system should enhance predictability, lessen administrative burdens, and be adaptable to external changes.

Innovation: The implementation of an innovation principle is advised. This would expedite the integration of the latest medical technologies into European healthcare systems, through the use of specific assessment pathways and early dialogues with developers.

Governance: The creation of a singular, dedicated structure to supervise and manage the regulatory system is recommended. This structure should have the power to make decisions at the system level.


To ensure that Europe maintains its high standards of care, and continues to leverage innovative medical technology, it is crucial to reform the existing regulatory framework. The solutions proposed by MedTech Europe provide a starting point for discussions among all stakeholders, with the aim of addressing the current challenges and reshaping the future of Europe’s healthcare system.

Reference url

Recent Posts

Health Economics and Outcomes Research

Health Economics and Outcomes Research in Global Healthcare

Explore how Health Economics and Outcomes Research (HEOR) is shaping the future of global healthcare. Read our latest article to learn more about the strategic approaches being adopted to maximise the impact of HEOR. #Healthcare #HEOR #GlobalHealthcare 🌍🩺📊 Read more here


Data Science Hub in Kenya: Innovating Health Equity

🌍 Exciting news! 🎉 Aga Khan University and the University of Michigan are joining forces to establish a data science hub in Kenya 🇰🇪. Using AI and machine learning, they aim to improve health equity and care delivery 🏥. #DataScience #AI #HealthEquity #Collaboration

When you partner with Syenza, it’s like a Nuclear Fusion.

Our expertise are combined with yours, and we contribute clinical expertise and advanced degrees in health policy, health economics, systems analysis, public finance, business, and project management. You’ll also feel our high-impact global and local perspectives with cultural intelligence.



1950 W. Corporate Way, Suite 95478
Anaheim, CA 92801, USA



© 2024 Syenza™. All rights reserved.