As the digital health industry rapidly evolves, it is crucial to ask whether current medical device regulations provide the assurance they promise. The regulatory landscape for digital health solutions has seen significant changes, but challenges persist, raising concerns about the effectiveness and support these frameworks provide.

Current regulatory landscape

In the UK, medical devices are regulated by the European Medical Devices Directive (MDD), which has historically allowed around 90% of devices to achieve Level 1 CE certification through self-certification, often with minimal external oversight . This approach raises concerns about the robustness and reliability of the assurances provided, as self-certification without external assessment may undermine confidence in the certification process. Under MDD, there is also no focus on cybersecurity or data, which may mean that the assurance provided may be less comprehensive than initially thought.

In contrast, the European Union has adopted the Medical Devices Regulation (MDR), which requires many digital health solutions to be CE Level 2 certified. This process involves independent assessments carried out by notified bodies, aimed at ensuring more rigorous assurance of safety and effectiveness.

Insights from recent research

A recent study, “Navigating Medical Device Certification: A Qualitative Exploration of Barriers and Enablers Amongst Innovators, Notified Bodies, and Other Stakeholders,” highlights several critical issues in the current regulatory framework:

1. Inconsistent interpretation: There is significant variation in how different Notified Bodies interpret the regulations, leading to confusion and frustration among stakeholders. This lack of uniformity undermines the reliability of the certification process and can lead to inconsistent results.

2. Limited consultation: Notified bodies are not authorized to provide consultations, particularly regarding clinical evidence. This limitation can hinder innovators by preventing early feedback that could improve compliance and streamline the regulatory process. While some argue that maintaining independence is crucial, others believe that consultation could significantly improve the regulatory experience while ensuring that these independent consultants do not become too expensive and out of reach for certain organizations.

3. Capacity issues: Many Notified Bodies are operating at or beyond capacity, with anticipated increases in demand, particularly with the 2024 MDR deadline for Notified Body applications, expected to exacerbate these issues. Small businesses face particular challenges accessing these overburdened agencies, which can stifle innovation.

4. Disadvantages for SMEs: Small and medium-sized enterprises (SMEs) often face complex and resource-intensive certification processes. Difficulties in accessing notified bodies and disproportionate demands on resources can hamper their ability to bring innovative solutions to market.

The proposal for a new path

In response to these challenges, NHS England, NICE and the Department of Health and Social Care (DHSC) have proposed a new pathway designed to improve the lifecycle management of medical devices:

• New cutting-edge technologies: The pathway facilitates more effective NICE assessments of the clinical and economic cost-effectiveness of new technologies, streamlining the assessment process and ensuring new products meet NHS standards.

Discussion: a positive but incomplete step

The proposed pathway represents an important and positive step toward addressing some of the existing challenges in medical device regulation. By integrating the entire life cycle of medical technologies, it aims to streamline processes and improve support at different stages of development. However, several issues remain unresolved:

• Inconsistent interpretation: The pathway does not resolve the problem of different interpretations by notified bodies, which continue to constitute a significant obstacle to obtaining reliable and uniform certification results.

• Capacity constraints: While this route can improve processes, it does not directly address the underlying capacity issues faced by notified bodies. The expected increase in product volumes, particularly with the MDR transition, poses a challenge. Questions remain about how NICE will effectively manage this increased workload and how it will make decisions on product prioritization.

• Self-certification issues: The use of self-certification without external evaluation (CE level 1 certification) does not inspire confidence in the robustness of the regulatory process. This lack of independent review can undermine confidence in certification and fail to adequately ensure safety and effectiveness. This also leaves room for inconsistencies in categorization and intended purpose. Self-certification can be difficult for small businesses, as there can be many differences in interpretation and navigation of the regulatory landscape when Notified Bodies are not involved.

• Ongoing Compliance Challenges: It is essential to maintain compliance throughout the product lifecycle. The proposed path does not fully address the challenge of ongoing compliance, particularly as products evolve and undergo updates. Ensuring continued compliance with regulatory standards is essential for long-term safety and effectiveness, particularly in the case of Class 1 certification.

Conclusion

The new pathway proposed by NHS England, NICE and DHSC offers a promising approach to improving the regulatory framework for medical devices. It aims to streamline processes and improve support for the different stages of the medical technology life cycle. However, to fully address the identified challenges, additional measures are needed to address issues related to inconsistent interpretation, capacity constraints, self-certification and ongoing compliance. Ongoing dialogue and collaboration between all stakeholders will be essential to ensure that the regulatory environment effectively balances safety, innovation and accessibility.

Authors

Liz Ashall Payne

CEO and Co-Founder, ORCHA Healthcare Ltd