As digital health technologies (DHTs) increasingly permeate the landscape of clinical trials, the European Medicines Agency (EMA) faces mounting pressure to evolve its regulatory frameworks to keep pace. This article explores the current guidelines and regulations set by the EMA, delves into the challenges these regulations encounter due to the rapid advancement of DHTs, and suggests key adaptations. By enhancing clarity, supporting innovation, and aligning with global standards, these changes or the release of a DHT guidance aim to optimize the use of DHTs in clinical research, ultimately benefiting patient care and medical progress across Europe.

Current EMA Regulations

The EMA oversees a comprehensive regulatory framework under the Medical Device Regulation (MDR, Regulation EU 2017/745), which became applicable on May 26, 2021. This regulation redefines the responsibilities of the EMA and national competent authorities in evaluating the safety, quality, and efficacy of medical devices, including those with ancillary medicinal substances or integral to medicinal products​​​. The MDR aims to ensure a higher level of health and safety protection for EU citizens using these devices. The scope of this regulation also covers in vitro diagnostic medical devices as per Regulation (EU) 2017/746, which came into effect in May 2022​. However, there isn’t much around DHT categorization except within existing device regulations.

Why The Need for EMA Regulatory Reform to Support DHTs?

The EMA’s creation of specific DHT guidance is crucial for several reasons. First, it would enhance regulatory clarity, allowing manufacturers to understand compliance and validation requirements better and streamline the approval processes for new technologies. Second, clear guidelines would support innovation by providing a reliable framework for developers to operate confidently. Moreover, DHT guidance ensures that DHTs meet high safety and efficacy standards, thus protecting patient health. Finally, EMA-specific guidances would help align European standards with global regulations, facilitating international cooperation and market entry.

Current Limitations with EMA Regulation on DHTs

Despite the advancements in regulatory frameworks, there are significant challenges in accommodating the rapid evolution and diversity of DHTs. The current guidelines may struggle with:

  • Rapid Technological Advancements: The speed of innovation in DHT often outpaces regulatory updates, leading to potential gaps in guidelines that adequately address all new technologies.
  • Classification and Risk Assessment: The classification system under the MDR, primarily focusing on risk levels, may not always reflect the actual risks associated with DHTs. For instance, medical device software frequently used in low-risk settings might still face stringent regulations applicable to higher-risk categories​. (EUR-Lex)​.
  • Integration of Digital and Conventional Devices: The regulations are also challenged by the need to integrate guidelines for digital tools with those for more conventional medical devices. The distinction between these can be blurred, complicating compliance and enforcement actions.
  • Global Harmonization: Differing regulations across jurisdictions can complicate the global rollout of new DHTs, where manufacturers must navigate varying requirements in Europe and worldwide.

Addressing these challenges requires ongoing updates to the regulatory framework and active engagement with technology developers, healthcare providers, and other stakeholders to ensure that regulations keep pace with technological advancements. This dynamic approach would help harness the full potential of DHTs while ensuring patient safety and efficacy of medical interventions.

How EMA Can Adjust its Regulations

The rapid development of DHTs necessitates changes to the EMA’s regulatory framework to fully leverage these tools in clinical research by developing DHT guidance. As demonstrated above, the current system, while robust, doesn’t fully accommodate the integration and dynamic nature of DHTs, especially in combined trials of medicinal products and medical devices. However, there are a few suggestions [1]:

  1. Risk-Based Approaches: Implement more nuanced, risk-based qualification pathways for DHTs, particularly for low-risk devices and exploratory use cases. This would align with approaches seen in other regions, such as the U.S., and streamline the use of DHTs in early trial phases without undue regulatory burdens.
  2. Regulatory Clarity for Combined Uses: Develop clearer guidelines for using non-CE marked DHTs and medical devices within clinical trials, addressing the complexities of Article 62 and Article 82 applications. This includes support for trials using DHTs as investigational tools without the intent for further device development.
  3. Integration of Regulatory Processes: Advocate for an integrated application process that reduces redundancy and simplifies regulatory submissions. This can be modeled after successful frameworks in other jurisdictions, facilitating smoother, faster trial setups that benefit from DHTs.
  4. Follow FDA’s Proactive Engagement Model: The EMA could consider adopting a similar approach to The FDA’s proactive engagement model for DHTs. The FDA encourages early interactions through pre-submission meetings, facilitating a smoother regulatory process by allowing developers to gain early feedback on their technologies. Additionally, establishing a DHT Steering Committee by the FDA has proven effective in guiding companies through the regulatory landscape, providing expert advice, and updating them on the latest practices and guidelines.

Adopting these strategies that could be incorporated in DHT guidance could help EMA streamline DHT integration and address rapidly evolving digital health technologies more efficiently​.

Summary

In summary, the rapid evolution of DHTs entails a robust and adaptive regulatory response from the EMA. As outlined, the current framework, though comprehensive, often lags behind technological advancements, leading to inefficiencies and missed opportunities. The EMA can better support integrating innovative technologies in clinical trials by adopting risk-based approaches, enhancing regulatory clarity, and integrating processes similar to the FDA’s proactive models. These steps are crucial for maintaining Europe’s competitiveness in the global healthcare market and ensuring the safety and efficacy of emerging digital health interventions.

References:

[1] Podhaisky, HP. Digital Health Technology (DHT) in European Clinical Trials, How to Improve the Status-Quo of the Regulatory Landscape?. Ther Innov Regul Sci (2024). https://doi.org/10.1007/s43441-024-00657-y

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Moe Alsumidaie Chief Editor
Moe Alsumidaie is Chief Editor of The Clinical Trial Vanguard. Moe holds decades of experience in the clinical trials industry. Moe also serves as Head of Research at CliniBiz and Chief Data Scientist at Annex Clinical Corporation.