Back to the list

Urgent Revision of MDR and IVDR in 2024: What Manufacturers Need to Know

News

1. MDR & IVDR: Current Medical Device Regulations in Europe


The MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation), introduced in 2017, significantly impacted European manufacturers. These regulations aim to enhance the safety, quality, and transparency of medical devices across the EU.


The MDR applies to medical devices like implants and pacemakers, while the IVDR covers diagnostic tests. Both impose strict requirements on technical documentation, clinical evaluation, and post-market surveillance. For manufacturers, this has meant longer and more expensive certification processes, but also an opportunity to ensure higher quality and patient safety.


A key element of these regulations is transparency, with the introduction of the EUDAMED database and stricter requirements for Notified Bodies. These changes aim to restore trust after past medical scandals. However, manufacturers, especially SMEs, face challenges with the associated costs and delays in achieving compliance.


Today, the MDR and IVDR frameworks are crucial in ensuring safe and reliable medical devices in the European market. Still, there is a need to strike a balance between innovation and patient protection. With upcoming revisions, manufacturers must stay informed and adapt to the new requirements to avoid shortages and remain competitive in the market.



2. The European Parliament’s Call to Revise MDR and IVDR (2024)


On October 23, 2024, the European Parliament issued an urgent resolution to revise the MDR and IVDR. This move follows challenges in implementing these regulations, particularly delays in certifying medical devices and in vitro diagnostics, as well as growing shortages of critical products. The Parliament emphasizes the need to reduce administrative burdens for manufacturers, especially SMEs, while maintaining high safety standards for patients.


The key points of this resolution include:

  • A call to simplify certification processes, which are seen as too lengthy and complex.
  • Improved transparency in compliance systems, including faster notifications from Notified Bodies.
  • The need to preserve innovation in the medical device sector while preventing manufacturers from leaving Europe for more favorable regulatory environments, such as the US.

The Parliament also raised concerns about the ability of current systems to support innovative devices, particularly in niche sectors such as pediatric or orphan devices. It recommends swift actions by 2025 to prevent worsening shortages and to ensure patients have access to the best available medical technologies.


In conclusion, this resolution highlights the urgent need to rethink the regulatory framework while considering the needs of both manufacturers and patients. For companies in the sector, these reforms may represent both opportunities and challenges, requiring proactive adaptation to remain competitive in the European market.



3. The Regulatory Agencies’ Response to MDR and IVDR Revisions


In response to the European Parliament’s call for rapid revisions to the MDR and IVDR, European regulatory agencies expressed concerns in a letter dated October 18, 2024. They warned that hasty changes could lead to unintended consequences and further disrupt the system. Their position is clear: any legislative change must be based on rigorous analysis and careful impact assessment to avoid creating additional complications for manufacturers and authorities.


The agencies also pointed out the potential risks of market disruption, with even more complex certification procedures and an impact on the availability of medical devices. They call for a balanced approach, where patient safety remains a priority, while maintaining clear and accessible procedures for manufacturers.


Medical device manufacturers should closely follow ongoing discussions, as rushed changes could not only complicate regulatory compliance but also affect their ability to innovate and keep their products on the European market.



4. Impact of MDR and IVDR on Medical Device Manufacturers


Since their implementation, the MDR and IVDR regulations have significantly altered how medical device manufacturers approach regulatory compliance. Their increased requirements for technical documentation, clinical evaluation, and post-market surveillance have led to a substantial rise in compliance costs. These costs especially affect SMEs, which struggle to keep up with the new procedures.


Furthermore, certification timelines have lengthened as Notified Bodies are often overwhelmed, delaying market access for products. These delays may push some manufacturers to consider relocating to less restrictive markets, such as the US, where regulations are perceived to be more innovation-friendly and conducive to faster commercialization.


One of the major impacts of these regulations is the growing gap between innovation and market access. European companies now face increasing safety demands alongside economic pressures, particularly in sectors where international competition is fierce. To remain competitive, manufacturers must adjust their strategies, reassess their costs, and, in some cases, explore alternatives like the US market.



5. The Future of MDR & IVDR: What Manufacturers Can Expect


As the MDR and IVDR reforms take shape, medical device manufacturers should expect changes that may ease some burdens while introducing new requirements. Potential reforms include the simplification of certification processes and improved coordination between Notified Bodies to reduce current bottlenecks.


Furthermore, calls for accelerated certification pathways for innovative devices, particularly in critical areas such as pediatric or orphan devices, could offer opportunities for companies ready to innovate.


However, caution remains essential. Companies must closely monitor the evolution of reform discussions, as any rushed revision could also create additional challenges, particularly in terms of regulatory compliance and extra costs related to adapting to new rules.


For manufacturers, the future of MDR and IVDR represents both a risky and promising terrain. They will need to quickly adjust their strategies to keep up with regulatory changes while maximizing the opportunities offered by innovations in the sector.


One of the major dangers remains regulatory uncertainty: frequent or poorly anticipated revisions could create an unstable environment for companies, forcing them to constantly adjust their internal processes. This uncertainty could slow innovation and increase the administrative burden, putting pressure on manufacturers’ internal resources.


Faced with these uncertainties, it is crucial for manufacturers to take steps now to prepare:

  • Strengthen internal compliance teams to better anticipate reforms and their implications.
  • Collaborate with external experts to assess risks and adjust strategies.
  • Invest in regulatory monitoring to stay up-to-date on MDR and IVDR developments and ensure rapid adaptation to new requirements.


6. Balancing Patient Safety and Innovation in Europe


One of the biggest challenges in regulating medical devices in Europe is finding a delicate balance between patient safety and technological innovation. On the one hand, MDR and IVDR have enhanced vigilance and transparency to protect patients from dangerous or defective devices. Previous scandals (such as faulty implants) highlighted the need for a robust framework to ensure that products on the European market are safe and effective.


However, these increased requirements can sometimes hinder innovation. The high compliance costs and long certification timelines can discourage companies, especially SMEs, from developing new devices or bringing innovative technologies to market. This dilemma is driving some manufacturers to leave the European market for regions with more favorable regulations, such as the US.


The ideal balance lies in regulation that protects patients while remaining flexible enough to encourage innovation. Solutions such as accelerated certification for high-potential devices, along with specific support for critical sectors like pediatric and orphan devices, could help Europe maintain its competitiveness while ensuring patient safety.


To ensure a sustainable future, it is imperative that authorities and companies collaborate to establish smart regulations, where the benefits to public health and the stimulation of innovation are equally considered.



Conclusion


In 2024, the MDR and IVDR regulations continue to evolve, reflecting both the need for patient safety and the growing demand for innovation in the medical device sector. While reforms are necessary to simplify certain processes and support SMEs, it is crucial not to compromise patient safety for the sake of efficiency. Finding a balance between these two opposing forces will be key to enabling Europe to remain competitive in the global market while ensuring safe and reliable healthcare.


Manufacturers will need to quickly adapt to new regulations while capitalizing on innovation opportunities offered by a more flexible regulatory framework. Proactive anticipation and close collaboration with authorities will be essential for successfully navigating this transition while maintaining patient trust in medical devices.



We’re Here to Help


Since the implementation of Regulation 2017/745, new requirements are demanded and are part of the documentation to be presented to the notified body (e.g., in-depth clinical evaluation review, PMS procedure, product validation CQ results, staff competence evidence, etc.).


CSDmed provides its expertise and a methodical approach to its clients—start-ups, manufacturers, importers, and distributors of medical devices—thanks to a team of experts and specialized consultants who can manage the MDR transition in its entirety.


🔗 Contact us and find out how we can help you.

HMA letter European Parliament Resolution