# AI Airlock Simulation Workshops

Source: https://www.keypedia.com/records/uk_mhra_guidance/uk-mhra/cd4259d7-3319-4f4c-8e1a-f3558306438e
Type: Guidance
Published: October 16, 2025
Updated: June 9, 2026

> The UK Medicines and Healthcare products Regulatory Agency (MHRA) recently facilitated a series of simulation workshops as part of its AI Airlock initiative to address regulatory challenges in healthcare technology. These sessions brought together a collaborative group including the MHRA, the National Institute for Health and Care Excellence (NICE), and the National Health Service (NHS), alongside various stakeholders from industry, academia, and clinical practice. While the provided text does not document specific company violations or inspection dates, it outlines the regulatory framework for managing artificial intelligence within the healthcare sector. The workshops focused on identifying key hurdles in the existing oversight process and fostering a shared understanding of technology risks. The primary outcome of these sessions is the development of a framework to shape future recommendations and regulatory reports. Required actions following these discussions involve integrating the insights gathered from these multi-disciplinary experts to refine official guidance for AI developers. By utilizing this collaborative approach, the MHRA aims to ensure that innovative medical technologies are evaluated through a robust, transparent, and clinically sound regulatory pathway before they reach the public.

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## Content

During the AI Airlock, the MHRA hosted Simulation workshops exploring key regulatory challenge areas. Each session brought together a diverse group of representatives from across industry, clinical practice, regulation, academia and technology. Participants included experts from the MHRA, NICE, NHS and a range of partner organisations. Their insights and collaborative contributions were instrumental in shaping the discussions and recommendations outlined in these reports.

## Attachments

- [AI Airlock Post-Market Surveillance Simulation Report](https://assets.publishing.service.gov.uk/media/68ee2540e7b6794c076bbdf5/AI_Airlock_PMS_Simulation_Report_MHRA_PHG26Aug25_Final.pdf)
- [AI Airlock Explainability Simulation Report](https://assets.publishing.service.gov.uk/media/68f0168a82670806f9d5e132/AI_Airlock_Explainability_Simulation_Report_MHRA_Final_v3.pdf)
- [AI Airlock Hallucination Simulation Report](https://assets.publishing.service.gov.uk/media/68f01680a8398380cb4ad141/AI_Airlock_Hallucination_Simulation_Report_MHRA_Final_v2.pdf)
- [AI Airlock AI In-Vitro Diagnostics Simulation Report](https://assets.publishing.service.gov.uk/media/6a27ccff56960b0542c0b1f5/AI_Airlock_AI_In-Vitro_Diagnostics_Simulation_Report.pdf)
- [AI Airlock Post Market Surveillance and PCCPs Simulation Report](https://assets.publishing.service.gov.uk/media/6a27ce35e13080622db3881c/AI_Airlock_Post_Market_Surveillance_and_PCCPs_Simulation_Report.pdf)
- [AI Airlock Scope of Intended Purpose Simulation Report](https://assets.publishing.service.gov.uk/media/6a27d04f56e988a798b3880e/AI_Airlock_Scope_of_Intended_Purpose_Simulation_Report.pdf)