The European Parliament recently adopted a resolution to revise key elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR), intending to address ongoing challenges ahead of the 2025 implementation deadline. The resolution seeks to improve patient access to critical medical products while streamlining regulatory processes.

Prepared by several parties, including the EPP, S&D, ECR, Renew Europe, and Verts/ALE, the resolution represents a non-binding legal intention to consider further changes. However, the final decision-making authority rests with the European Commission, meaning the future of these regulations will continue to evolve.

The Key Elements

The resolution outlines several key proposals aimed at improving the regulatory landscape for medical devices and diagnostics. These include reducing certification bottlenecks to ensure the continuous availability of critical products, introducing an accelerated approval process for innovative technologies, particularly in areas such as orphan drugs and pediatric devices, and enhancing transparency and coherence between notified bodies.

It also seeks to support small and medium-sized enterprises (SMEs) by reducing administrative burdens, while strengthening governance to ensure a more efficient, sustainable system that ultimately benefits patient outcomes. 

While these changes sound promising, the question remains: what exactly do they imply for the MDR and IVDR? And why, after just a few years since their implementation in 2017, is there an “urgent” need to revise these regulations? The resolution reflects persistent concerns that certification, innovation, and access issues persist despite the original regulations’ intentions.

Understanding the Resolution

To fully understand the intent behind the recent resolution revising the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR), we must first look back at the history of these regulations. Originally introduced to strengthen patient safety, transparency, and clinical performance standards, the MDR and IVDR aimed to improve patient outcomes while fostering innovation in the medical device and diagnostic sectors. The need for reform became clear following high-profile incidents, such as the breast implant scandal, which exposed the dangers of poorly regulated medical devices under the previous EU Directives. These issues prompted an overhaul of the regulatory framework to create a safer, more transparent system that harmonizes standards across Europe, aligns with international benchmarks, and ensures the highest levels of safety.

The first “consolidated” versions of the MDR and IVDR were published in 2014, and even a decade later, they remain under debate. From the beginning, the EU Commission’s official efforts, particularly through the Medical Devices Coordination Working Group (MDCG), have focused on evaluating and, if necessary, improving or adapting these regulations. Significant guidance has been published to support manufacturers or other economic operators and Notified Bodies in the interpretation of the IVDR or MDR requirements. Over the years, the EU Commission has worked diligently to adapt the old system to these new standards and to help navigate the complexities of the updated requirements.

There is nothing inherently wrong with re-evaluating the regulations, and this is exactly what is happening now. As part of a formal process by the Medical Devices Coordination Working Group (MDCG), the EU Commission has announced its strategy for future evaluation of the MDR/IVDR—a resolution that may also be viewed as a comment on this effort. 

What’s Missing Today for Manufacturers to Fully Comply with the MDR and IVDR?

The recent resolution’s general recommendations do not clearly outline what specific changes are needed, why they are necessary, or who will be responsible for implementing them. Of course, it is always valuable to re-evaluate over time, something medical device manufacturers are familiar with through re-validations. However, the resolution does not offer any new concrete steps, detailed updates to specific parts of the regulations, or practical solutions.

Certain groups of devices, such as orphan drugs or pediatric devices cited in this resolution, may not yet be adequately addressed in the existing framework and could benefit from a more tailored approval process or a fast-track route to market. If this resolution aims to address such gaps, it should be seen as a welcome push for the EU Commission to focus on these areas, ensuring that innovative products reach the market more easily and efficiently.

The resolution could also serve as a wake-up call for working groups within the EU Commission to prioritize topics critical to patient care, particularly those concerning devices related to innovative and life-saving technologies. We all want access to such devices when we need them. The overall goal is to prevent shortages of essential products while upholding safety standards. However, access to innovation should not come at the cost of patient safety.

That said, it is essential to understand that this resolution should not be seen as a call for discussions that could lead to further delays or as a sign of significant unresolved issues in the EU’s regulatory framework. In fact, most issues have already been addressed, with guidance documents published, and notified bodies now have sufficient capacity to support manufacturers effectively and flexibly.

What’s Next for MDR/IVDR?

Given the extensive groundwork already laid by the EU Commission in addressing the MDR and IVDR, it’s uncertain whether this new resolution will lead to substantial, rapid adjustments to the regulations. The ambitious 100-day timeline, which aims for actionable changes by early 2025, may be overly optimistic given the complexity of the topics and nuanced descriptions of the proposed changes. The MDR and IVDR have demonstrated that meaningful regulatory shifts require time, thorough assessment, and input from diverse stakeholders.

This resolution isn’t just a call for quick fixes; it’s a reminder of the importance of balanced, thoughtful review across the medical device framework. By pushing for adaptable solutions, particularly for complex and underserved device categories, it encourages regulators and industry players to work together on a sustainable path forward that keeps patient care at the center.

Article source：MPO