Compliance & Regulation

9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond

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9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond

Jama Software is always looking for news that would benefit and inform our industry partners. As such, we’ve curated a series of customer and industry spotlight articles that we found insightful. In this blog post, we share an article from MedDevice Online, titled “9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond”, and written by Marcelo Trevino.

9 Strategies To Overcome Challenges In The EU Medical Device Market In 2025 And Beyond

Global frameworks offer valuable insights for Europe as the region is currently working to refine its regulatory systems. While Europe is a significant player in the medical device market, the MDR transition has created challenges driven in part by higher costs and timelines due to stricter requirements that have extended approval timelines, increasing costs for manufacturers. Additionally, a shrinking pool of notified bodies has created bottlenecks, delaying device reviews and approvals. The EU MDR demands extensive pre-market clinical data, which has raised costs and delayed approvals. Additionally, lack of harmonization across member states complicates emergency approvals, as seen during the COVID-19 pandemic. This has resulted in a significant number of medical device manufacturers deprioritizing Europe as a launch market, preferring regions with clearer pathways. However, medical device manufacturers, regulators, and other stakeholders have an opportunity to mitigate these challenges by implementing the following strategic solutions to ensure that Europe remains a hub for medical innovation.

1. Enhance Predictability and Transparency In Regulatory Processes

The unpredictability of the regulatory process under MDR poses a significant challenge for manufacturers. Structured dialogue provides a valuable solution by enabling early engagement with notified bodies. This process allows manufacturers to present their clinical strategies, product designs, and evidence plans, ensuring alignment on regulatory expectations. When regulators and manufacturers work collaboratively from the start, costly errors, such as insufficient clinical data or inappropriate trial designs, can be avoided. Additionally, regulators need to issue more detailed guidance to clarify what constitutes acceptable clinical evidence, particularly for innovative products. Leveraging real-world evidence (RWE) from other jurisdictions, such as data from FDA-approved devices, can further reduce redundant studies and expedite European approvals. Equally important is training regulators and notified body auditors in emerging technologies, ensuring that evaluations are both informed and consistent. By addressing these areas, Europe can create a regulatory environment that fosters clarity and efficiency.

2. Leverage Conditional Certification For Innovative Devices

Innovative devices often face challenges in providing long-term clinical data due to their novelty, which can delay market entry. Conditional certification offers a balanced pathway by allowing such devices to reach patients sooner while requiring ongoing evidence collection post-launch. For example, some devices to treat critical health conditions have been granted conditional certification through some notified bodies based on strong initial safety and efficacy signals. Through rigorous post-market clinical follow-up (PMCF), manufacturers can demonstrate continued safety and effectiveness, ultimately transitioning to full certification. Expanding this framework across Europe would allow more innovative devices to address unmet medical needs without undue delay. Regulators should formalize the conditional certification process with standardized criteria and timelines for post-market data submission, ensuring consistency across member states. This approach not only accelerates patient access to cutting-edge treatments but also provides manufacturers with real-world data to refine their products and strengthen market positions.

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3. Promote Innovation-Friendly Pathways

Globally, regions have implemented streamlined pathways to fast-track the approval of high-impact devices. Europe must adopt similar measures to remain competitive. The FDA’s Breakthrough Devices Program, which prioritizes devices for life-threatening conditions, provides an exemplary model. In Europe, the U.K.’s Innovative Devices Access Pathway (IDAP) offers a promising localized framework. By selecting devices with transformative potential, IDAP helps manufacturers navigate regulatory approvals while ensuring compatibility with the National Health Service (NHS). Expanding such programs across the EU would create harmonized support for innovative products. Additionally, establishing a centralized EU innovation authority could streamline fast-tracking efforts, provide consistent eligibility criteria, and coordinate expedited reviews with notified bodies. Such initiatives would encourage manufacturers to reprioritize Europe as a launch market for groundbreaking medical technologies.

4. Address Capacity Constraints In Notified Bodies

Limited capacity within notified bodies is a critical bottleneck in the regulatory process. These organizations often struggle to meet the demand for timely reviews due to a shortage of trained personnel and the increased complexity of MDR compliance. Expanding capacity requires investment in training new auditors and regulatory experts. Industry associations and governments should collaborate to develop accelerated certification programs, focusing on skills required for evaluating innovative devices. Additionally, digital transformation can enhance efficiency within notified bodies. Electronic submission platforms and real-time tracking systems can reduce administrative burdens, allowing experts to focus on substantive evaluations. Some notified bodies are also establishing dedicated innovation teams to prioritize reviews for novel devices, ensuring that cutting-edge products receive timely attention. Addressing these capacity constraints will streamline the review process, benefiting both manufacturers and patients.

5. Harmonize Regulatory Practices Across Europe

Fragmentation in regulatory interpretations among EU member states creates inconsistencies that hinder market entry for manufacturers. Harmonizing these practices is crucial to fostering a predictable and efficient system. Standardized criteria for conformity assessments would ensure that notified bodies across Europe apply uniform standards, reducing disparities in evaluation outcomes. Mutual recognition agreements (MRAs) with regions like the United States could further streamline market entry. For example, a device approved by the FDA could leverage its existing data for European approvals, reducing duplication of effort. Additionally, a centralized EU pathway for innovative devices would eliminate member state disparities, providing manufacturers with a clear and consistent process. Harmonization not only simplifies regulatory navigation for manufacturers but also enhances patient safety by ensuring uniform standards across the region.

6. Support Manufacturers Of Low-Risk Devices

While high-risk devices often garner attention, low-risk devices face their own challenges, particularly in meeting unclear data requirements under MDR. Regulators need to provide tailored guidelines for low-risk devices, detailing acceptable forms of evidence such as literature reviews, usability studies, and equivalence data. Simplifying approval pathways for these devices would reduce the regulatory burden, allowing manufacturers to bring products to market more efficiently. Collaborative initiatives, such as data-sharing consortiums, could further support manufacturers by pooling anonymized evidence from similar products. These measures would ensure that low-risk devices, which often address essential but less critical medical needs, reach patients without unnecessary delays.

7. Expand Collaboration And Education

Building a collaborative ecosystem is essential for addressing systemic challenges in the European regulatory framework. Regular industry–regulator forums can facilitate open communication, enabling stakeholders to share insights, identify bottlenecks, and co-develop solutions. Such forums also provide an opportunity to align best practices and refine regulatory processes. Education plays a key role in empowering manufacturers, particularly small and midsize enterprises, to navigate the complexities of MDR. Tailored training programs focused on structured dialogue, clinical evidence requirements, and post-market surveillance can equip these organizations with the knowledge needed to comply effectively. A collaborative and well-educated ecosystem benefits all stakeholders by fostering alignment and reducing inefficiencies.

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8. Embrace Digital Transformation

Digital tools have the potential to revolutionize regulatory processes and compliance. EUDAMED, Europe’s centralized database for medical devices, promises to enhance transparency and traceability. Accelerating its full implementation would allow manufacturers and regulators to streamline device registration, track certifications, and monitor post-market performance. Beyond centralized databases, artificial intelligence (AI) can play a transformative role in regulatory reviews. AI algorithms can analyze clinical data, identify gaps, and predict risks with greater efficiency, reducing the time required for evaluations. Additionally, real-time data collection from connected devices can enhance post-market surveillance, ensuring patient safety while providing manufacturers with actionable insights. Embracing digital transformation will not only streamline regulatory processes but also improve the overall quality and safety of medical devices.

9. Advocate For Legislative Revisions

While manufacturers must work within existing regulations, collective advocacy can influence future policies to better balance innovation and safety. Industry coalitions, such as MedTech Europe, can play a crucial role in presenting a unified voice to policymakers. By highlighting the economic and public health benefits of expedited innovation pathways, these coalitions can make a compelling case for regulatory reforms. For example, demonstrating how delays in device approvals affect patient outcomes and healthcare systems can galvanize support for streamlined processes. Advocacy efforts should focus on expanding conditional certification, simplifying requirements for low-risk devices, and creating harmonized pathways for innovative products. Engaging in public consultations and contributing to expert panels further ensures that manufacturers have a direct role in shaping the future regulatory landscape.

Conclusion

Innovation in medical devices is at a crossroads, where the imperative to advance technology must align with regulatory rigor and ethical responsibility. Structured dialogue, harmonized pathways, and collaborative frameworks provide a road map for fostering innovation in Europe.

A collaborative, forward-thinking approach among manufacturers, regulators, and policymakers will ensure that Europe remains at the forefront of medical technology advancements. By implementing different approaches targeting existing challenges, the European medical device market can overcome them, fostering an environment that supports both innovation and patient safety once again.

Through collaboration, transparency and by learning from the global best practices that also can target regional issues, Europe can recover its leadership in medical technology and ensure that innovative devices reach patients in need, contributing to the transformation of the future of healthcare.

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