Artificial Intelligence in healthcare is revolutionising the way of diagnosing, treating, and monitoring patients. Its use is transforming the medical devices industry, defining new machine’s abilities to make decisions and perform tasks typically given to humans. All these groundbreaking technologies are inevitably bringing regulators to develop new rules and guides in order to ensure that medical devices are safe.
AI-Airlock sandbox in support of innovation and compliance
At the end of October 2023, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the AI-Airlock sandbox, a regulator-monitored virtual area for developers of AI medical devices deployed in 2024. A sandbox is a testing environment, a space where developers can run codes in an isolated environment without having an impact on the surrounding network. The AI-Airlock will help innovators to develop compliant products, specifically when it comes to collecting robust evidence to assess safety and efficiency of medical devices. Developers will be able to understand the requirements to develop safe software and AI medical devices.
MHRA Guidance on Software and Artificial Intelligence (AI) as a Medical Device
Manufacturers of AI medical devices and software shall comply with the EU Medical Devices Regulations or with the UK Medical Devices Regulations to sell their products in Great Britain. There is plenty of guidance documents that manufacturers can consult to understand how such products are regulated. The MHRA recently updated the Guidance on Software and Artificial Intelligence (AI) as a Medical Device, which gives an overview of classification, regulatory framework, post-market surveillance, and vigilance, among other outputs.
For medical devices software (MDSW) and AI medical devices, Obelis will:
- Acts as your EU authorised representative or UK responsible person
- Verify that the documentation is compliant with the applicable legislation
- Search a notified body for you
- Help you compile the documentation
- Keep you up to date about any changes that impact your devices
How can Obelis help you?
Obelis is a well-known company in the regulatory sector, offering representative and consultancy services for 35 years. We are the ideal regulatory partner for you: our team will be at your side during the whole compliance process, ensuring that your cosmetic products can enter the UK market without any issues.
Check our cosmetic services and contact us for further information on how we can support your business.
References:
- Gov.uk (2023) MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers. Retrieved on 08.11.2023.
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