Medical Devices
Technical Team

Artificial Intelligence (AI) in Medical Devices (MD)

Our AI and medical device experts help you align innovation with global governance and standards requirements.

AI Expertise

Trusted expertise for AI-enabled medical devices

As your independent conformity assessment and regulatory experts in AI, we help you align innovation with global and local requirements across compliance, governance, and medical device standards.

AI-enabled medical devices must meet strict MDR, IVDR and emerging EU AI Act requirements. While AI is transforming healthcare, it also introduces new regulatory and risk management challenges.

As an independent Notified Body, BSI supports manufacturers with conformity assessment, helping ensure AI systems meet safety, performance, and compliance requirements.

By aligning innovation with regulatory requirements, manufacturers can bring AI-enabled medical devices to market with confidence.

Our AI experts conduct dedicated AI reviews within MDR and IVDR conformity assessments, evaluating the safety, performance, and risk management of AI components in line with regulatory expectations.

As a designated MDR and IVDR Notified Body, BSI has completed over 100 AI system reviews, supporting manufacturers in demonstrating compliance with regulatory requirements.

Our AI expert reviews assess safety, performance, and risk management of AI-enabled medical devices as part of each conformity assessment.

Start your AI conformity assessment with BSI and demonstrate that your device meets regulatory expectations.

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AI services

Information about services, regulations, and BSI

Our AI Performance service provides independent assessment of how AI systems perform – including accuracy, robustness, and bias. By verifying performance claims using recognized standards, we help you demonstrate transparency, credibility, and responsible AI deployment. With BSI, you can show stakeholders that your AI works as intended.

Explore AI Performance
ISO/IEC 42001 certification provides a structured framework for managing AI systems, including governance, risk management and accountability. For organizations developing AI-enabled medical devices, certification helps demonstrate alignment with global AI standards and supports regulatory compliance in highly regulated environments.

Explore ISO/IEC 42001
The EU AI Act will introduce additional requirements for AI-enabled medical devices, alongside MDR and IVDR. You must ensure compliance across both regulatory frameworks, covering safety, transparency and risk management. Understanding how the AI Act applies to medical devices is critical to maintaining market access and demonstrating responsible AI use.

Learn more about the EU AI Act
BSI’s AI Regulatory Services team combines expertise across MDR, IVDR and global AI governance frameworks. As an independent standards body and Notified Body, BSI provides trusted third-party assessment of AI systems, supporting safe and compliant innovation in medical devices.
Our AI Foundation Framework helps you to demonstrate accountability where it matters most, with a modular approach built on global standards.

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