The EU Parliament votes on a resolution to revise specific parts of the MDR and IVDR

On October 23, the European Parliament adopted a resolution revising specific elements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostic Devices Regulation (IVDR). This resolution intends to address ongoing challenges in implementing the regulations by 2025 and to improve patient access to important medical products.

This resolution was prepared by several parties (EPP, S&D, ECR, Renew Europe, Verts/ALE) and represents a non-binding legal intention from the EU Parliament to consider further changes. The final decision-making rests with the EU Commission.

Key elements of this resolution include:

• Reducing certification bottlenecks and streamlining certification processes to ensure the continued availability of critical medical devices and diagnostics.
• Supporting innovation by introducing an accelerated approval process for innovative medical technologies, particularly for orphan drugs, pediatric medical devices, and other devices that can address unmet medical needs.
• Improving transparency and coherence between notified bodies.
• Assisting small and medium-sized enterprises (SMEs) in navigating the regulatory environment with fewer administrative challenges.
• Enhancing governance to oversee the regulatory system, aiming for efficiency, sustainability, and better patient outcomes.

This all sounds nice. But what does this resolution actually mean regarding potential additional changes to the MDR or IVDR? And why is there an “urgent” need to revise these regulations, which came into effect in 2017?

Overview of the resolution

To understand this, we need to go back in history and remember that the MDR and IVDR were adopted as a more robust regulatory framework for medical devices and in vitro diagnostics (IVDs) to ensure higher standards of safety, transparency, and clinical performance while fostering innovation. This framework aims to enhance patient safety and harmonize the system to a common state-of-the-art. The breast implant scandal and thousands of similar issues identified with insufficiently controlled medical devices under the EU Directives triggered the establishment of this new framework.

​​The first compromised version of the MDR/IVDR was published in 2014, and now, 10 years later, we are still trying to improve it. There is nothing inherently wrong with re-evaluation of the regulations and this is what has been done now as part of a formal process of the Medical Devices Coordination Working Group (MDCG), where the EU Commission  announced their strategy on how they will evaluate the MDR/IVDR. It is important to acknowledge that the EU Commission and its working groups have worked diligently over the years to adapt the existing old system and related standards to these regulations. They have published multiple guidance documents (MDCG) for manufacturers, as well as for other economic operators and Notified Bodies, to assist in navigating the new requirements.

So, what is missing today for manufacturers to comply with the MDR or IVDR?

Most of the topics outlined in this resolution are quite general, and therefore, the resolution does not specify what needs to be changed, why, and by whom. Of course, it is always beneficial to re-evaluate things over time—medical device manufacturers are familiar with this process from re-validations.

There may also be specific device groups (e.g., orphan drugs) that have not yet been adequately addressed in the current regulations and may require more attention, a specific approval process, or a fast-track route to market so that patients can benefit from them and innovation is not stifled. If this resolution aims to achieve that, it serves as a welcome call for action for the EU Commission to focus on such improvements for specific categories of devices.

This resolution could also encourage related EU Commission working groups to prioritize certain topics, particularly regarding innovative and life-saving technologies in patient care. We all want access to such innovative devices when needed; the EU framework should not create shortages of essential products. However, the primary concern must be the safety of these medical devices.

However, the resolution should not be seen as a call for general discussion leading to further delays, nor should it be interpreted as an indication that significant problems still exist within the current EU framework. This would not be fair. Most of these issues have been resolved, interpretation for most topics have been published as well as standards revised and Notified Bodies currently have sufficient capacity. In my experience, the Notified Bodies are also very communicative and open to accepting tailored solutions for specific devices.

Next steps

Finally, considering the significant work the EU Commission has already undertaken on these topics and the vague description of the required actions in this resolution, it remains unclear whether this resolution will lead the EU Commission to implement rapid additional changes to the MDR or IVDR. The timeline of 100 days until Q1 2025 is quite unrealistic and overly ambitious given the complexity of the issues involved. If we've learned anything from the MDR/IVDR over the last years, it is that careful consideration is essential before making decisions. This process requires collaboration among all stakeholders, including industry feedback. This is what the message of this resolution should be. A reminder and a call to action for all players to re-evaluate carefully the current status and find flexible solutions for specific categories of devices in this complex medical landscape.

Facing challenges with the MDR/IVDR transition? Reach out to Pure Global for expert assistance. We’re here to help you navigate regulatory barriers and ensure compliance.

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