ORCHA Guest Blog: Is Medical Device Regulation Providing the Assurance You Think for Digital Health?

As the digital health sector rapidly evolves, it's crucial to question whether current medical device regulations provide the assurance they promise. The regulatory landscape for digital health solutions has seen significant changes, yet challenges persist, raising concerns about the effectiveness and support these frameworks offer.

Current Regulatory Landscape

In the UK, medical devices are regulated under the European Medical Device Directive (MDD), which has historically allowed around 90% of devices to achieve Level 1 CE certification through self-certification, often with minimal external scrutiny. This approach raises concerns about the robustness and reliability of the assurances provided, as self-certification without external evaluation can undermine trust in the certification process. Under the MDD, there isn’t a huge emphasis placed on cybersecurity or data either, which can mean the assurance provided can be less complete than first thought.

In contrast, the European Union has adopted the Medical Device Regulation (MDR), which requires many digital health solutions to undergo Level 2 CE certification. This process involves independent evaluations by notified bodies, aiming for a more rigorous assurance of safety and efficacy.

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 within the current regulatory framework:

Inconsistent Interpretation: Significant variation exists in how different notified bodies interpret regulations, leading to confusion and frustration among stakeholders. This lack of uniformity undermines the reliability of the certification process and can result in inconsistent outcomes.

Limited Consultation: Notified bodies are not allowed 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 enhance the regulatory experience whilst working to ensure those independent consultants do not become too expensive, and out of reach for some organisations.

Capacity Issues: Many notified bodies are operating at or beyond capacity, with anticipated demand surges, especially with the 2024 MDR deadline for notified body applications, expected to exacerbate these issues. Smaller companies face particular challenges in accessing these overstretched bodies, which can stifle innovation.

Disadvantages for SMEs: Small and medium-sized enterprises (SMEs) often struggle with the complex and resource-intensive certification processes. The difficulties in accessing notified bodies and the disproportionate resource demands can inhibit their ability to bring innovative solutions to market.

The New Pathway Proposal

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

Early-Stage Technologies: The pathway offers additional support for technologies that need further evidence generation. This aims to help innovators meet regulatory requirements and improve their chances of successful certification.

New, Cutting-Edge Technologies: The pathway facilitates more efficient NICE assessments of clinical and cost-effectiveness for new technologies, streamlining the evaluation process and ensuring that new products meet NHS standards.

Existing Technologies: The focus on maximizing the value of technologies already in use within the NHS aims to drive better health outcomes and enhance the benefits of current innovations.

Discussion: A Positive Step but Incomplete

The proposed pathway represents a significant and positive step towards addressing some of the existing challenges in medical device regulation. By integrating the entire medtech lifecycle, it aims to streamline processes and improve support for various stages of development. However, several issues remain unresolved:

Inconsistent Interpretation: The pathway does not address the problem of varying interpretations by notified bodies, which continues to be a significant barrier to achieving reliable and uniform certification outcomes.

Capacity Constraints: While the pathway may improve processes, it does not directly tackle the underlying capacity issues faced by notified bodies. The anticipated surge in product volumes, particularly with the MDR transition, poses a challenge. Questions remain about how NICE will manage this increased workload effectively and how they will make decisions on prioritising products.

Self-Certification Concerns: The reliance on self-certification without external evaluation (CE certification Level 1) does not inspire confidence in the robustness of the regulatory process. This lack of independent scrutiny can undermine trust in the certification and may not adequately ensure safety and efficacy. This also allows room for inconsistencies in categorisation and intended purpose. Self-certification may prove difficult for smaller companies as there can be many differences in interpretation and navigating the regulatory landscape when notified bodies are not involved.

Ongoing Compliance Challenges: Maintaining compliance throughout the product lifecycle is critical. The proposed pathway does not fully address the challenge of continuous compliance, especially as products evolve and undergo updates. Ensuring ongoing adherence to regulatory standards is essential for long-term safety and efficacy, especially so in the case of Class 1 certification.

Disadvantages for SMEs: The pathway does not specifically address the systemic disadvantages faced by SMEs, who may still struggle with accessing resources and navigating the regulatory landscape.

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 enhance support for different stages of the medtech lifecycle. However, to fully address the challenges identified, additional measures are needed to resolve issues related to inconsistent interpretation, capacity constraints, self-certification, and ongoing compliance. Ongoing dialogue and collaboration among all stakeholders will be essential to ensure that the regulatory environment effectively balances safety, innovation, and accessibility.

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