Day 2 - Tuesday 16th JuneTuesday, 16 June 2026 - CEST Time Zone

• MHRA's AI Airlock launched in 2024, is the UK’s first regulatory sandbox for AI as a Medical Device (AIaMD). It provides a safe, collaborative environment for testing real-world AI medical products against regulatory challenges, enabling developers, regulators, and partners to co-create solutions that inform future guidance and policy.
• This presentation will share insights from the pilot programme including establishment of the sandbox, key milestones and regulatory challenges investigated and lessons learned. The programme is now in its second phase and key details about the candidates and products selected for Airlock will be provided, including the criteria for their selection. We will share important learnings from the candidates’ experiences—what worked well, common challenges faced, and successes achieved.
• Finally, the presentation will address future plans for Airlock, focusing on how the programme enables an innovative approach to regulatory policy, emphasise the importance of continuous engagement as a regulator and why designing regulations with real world input is effective.

• Methodology presentation: Establishing comparative performance benchmarks for multiple generic and domain-specific large language models (LLMs) for SLRs and by testing a range of datasets, including publicly available SLRs and anonymized contributor datasets for SLRs representing different medical device product categories and therapeutic fields.
• Testing results: Benefits in terms of both efficiency and accuracy - reduce reviewer SLR completion times over manual methods while improving LLM model performance and data/evidence quality by 7-25%. By focusing on user-friendliness, this research project also aims to reduce the time to train intermediate staff on AI. On a wider scale, the project anticipates a dramatic reduction in the time taken for industry standard adoption.
• Achieving Notified Body Acceptability: Demonstrate that the output of AI-driven data extraction—specifically the automated detection of longitudinal adverse events—is supported by a transparent, auditable data provenance trail that satisfies regulatory scrutiny under the EU MDR/IVDR.
• Defining the Role of Human Oversight: Establish best practices for the "human-in-the-loop" verification process, outlining when and how subject matter experts must validate LLM outputs to maintain regulatory compliance and manage risk.
• Validating AI Accuracy: Address the industry hurdle of accepting that a validated LLM model can achieve higher accuracy and lower error rates than manual human review, driving the 7-25% improvement in data quality

• Exploring the regulatory challenges and requirements for managing risks associated with AI-based Medical Device Software (AI-MDSW) under the EU AI Act.
• Discussing practical strategies for integrating AI risk management into existing regulatory frameworks to ensure compliance and patient safety.

A comprehensive workshop on biological evaluation and safety assessment for medical devices. This specialized session focuses on ensuring continued device safety through expert-led discussions and practical training session.

Featuring expert-guided sessions on the following topics:

• Foundations to biological evaluations
• Process in creating a biological evaluation plan
• Test design for BEP
• Understanding and interpreting test results
• Transitioning into a biological evaluation report
• Toxicology (evaluating compounds, MOS calculation per ISO 10993-17, group division and tox assessment)
• Life of the Biological Evaluation

• Exploring real-world examples highlighting cybersecurity challenges faced by software-based medical devices.
• Discussing strategies for managing evolving cybersecurity threats while ensuring patient safety and regulatory compliance.
• Insights into proactive risk management approaches and best practices for safeguarding medical device software in a dynamic threat landscape.

For more information, please contact Neha Singh at niha.singh@informa.com

• Delving into the regulatory landscape for AI-enabled medical devices in China, including key requirements and recent updates.
• Discuss challenges and opportunities for manufacturers navigating China’s unique regulatory framework for AI-driven technologies.

This specialized workshop addresses the critical intersection between regulatory compliance and market access success for medical device professionals. As regulatory affairs specialists increasingly need to understand downstream commercial implications of their regulatory strategies, this session provides essential knowledge on how regulatory decisions directly impact reimbursement outcomes. Participants will learn to optimize regulatory pathways not just for approval, but for successful patient access and sustainable market adoption.

Workshop discussion points:

• Introduction To The Evolving Reimbursement Landscape in MedTech
• Strategies for Navigating Reimbursement Challenges
• Leveraging Data for Reimbursement Success
• SME-Specific Challenges and Opportunities
• Global Market Access Considerations
• Future Trends in Patient Access & Reimbursement