Hogan Lovells publishes white paper on the applicability of the AI Act to clinical investigations of AI-based medical devices

The White Paper identifies the current regulatory ambiguity within the European Union, particularly the uncertainty about whether and to what extent the AI Act applies to clinical investigations of AIMD that have not yet obtained CE marking. This confusion arises due to inconsistencies between the AI Act and the MDR, posing significant challenges for manufacturers, regulators, and healthcare providers involved in the development and deployment of these innovative medical devices.

Why this Regulatory Ambiguity Matters

The paper identifies the unclear boundaries between the AI Act and MDR, specifically focusing on whether clinical investigations of AIMD fall within the research exemption under the AI Act or are subject to additional approval requirements.

The uncertainty surrounding whether the AI Act applies to clinical investigations of AIMDs is not just a legal technicality—it poses significant practical challenges:

- Regulatory Uncertainty: Without clear guidance, manufacturers may face delays and inconsistencies in compliance, which can disrupt the development process and lead to a fragmented regulatory environment across the EU.

- Patient Safety and Data Integrity: The AI Act includes critical safeguards for high-risk AI systems. If these do not apply during clinical investigations, there may be insufficient oversight of AI components, potentially compromising patient safety and the reliability of clinical data.

- Inconsistent Regulation: Failing to apply the AI Act consistently across all stages of a product’s lifecycle could undermine the effectiveness of AI regulations, making it harder to ensure that AI systems are safe, ethical, and effective.

- Impact on Innovation: The lack of regulatory clarity may discourage innovation, as companies could be hesitant to invest in new AIMDs without understanding the full scope of regulatory requirements. This could diminish the competitiveness of the European medical technology sector.

In light of these challenges, Hogan Lovells' White Paper calls on the European Commission and national legislators to issue clear guidelines and align regulatory frameworks to ensure that stakeholders can navigate the complexities of conducting clinical investigations of AIMD without unnecessary administrative burdens or risks.

The paper emphasizes the importance of collaboration between regulatory bodies, industry representatives, and legal experts to develop comprehensive guidance that addresses the specific challenges posed by the AI Act.

Arne Thiermann, Partner at Hogan Lovells, commented, "As AI continues to transform the medical device industry, it is crucial that we have a clear and coherent regulatory framework. This White Paper aims to initiate discussions and actions that hopefully lead to the necessary clarifications."

The White Paper is available for download on the Hogan Lovells website.