What's inside:

Recent advancements in Artificial Intelligence (AI) are transforming the healthcare sector, driving digital innovation in medical devices. From AI-powered breast cancer detection in mammograms to wearable patient monitoring solutions and autonomous robotic surgeons, AI is revolutionizing patient care.

Download this whitepaper to discover how manufacturers can seamlessly integrate AIA requirements into their existing MDR compliance frameworks, ensuring readiness for the evolving AI regulatory landscape:

  • Clear insights: Understand the EU AI Act with jargon-free explanations, making it easy to grasp what it means for your business and how it interplays with the MDR.
  • Expert analysis: Learn from BSI, an accredited AI Management System Certification Body recognized by Raad voor Accreditatie (RvA), committed to advancing AI development and ensuring compliance with global standards. 
  • Strategic implications: Explore compliance requirements and uncover innovation opportunities to align your AI strategy with the EU AI Act and MDR to stay ahead of regulatory changes.
  • Infographic + Video: Get a visual breakdown of key information and an insightful, concise video explaining the AIA and its impact on medical devices.

Download the whitepaper

Navigate the complexities of AI and the MDR with BSI Compliance Navigator


Requesting a free trial to BSI Compliance Navigator provides medical device manufacturers with direct access to essential regulatory documents, including key standards and guidance documents. These regulatory documents are vital for ensuring compliance in the evolving landscape of medical devices and AI integration.

By signing up for a free trial, manufacturers can take advantage of a personalized content comparison and a detailed walkthrough of the platform, allowing them to evaluate if BSI Compliance Navigator meets their specific regulatory needs. This trial is an excellent opportunity to explore how the platform can streamline compliance with relevant standards, regulations and guidance documents.

Including but not limited to:

  • 2024/1689/EU: REGULATION (EU) 2024/1689 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 June 2024 laying down harmonised rules on artificial intelligence and amending Regulations (EC) No 300/2008, (EU) No 167/2013, (EU) No 168/2013, (EU) 2018/858, (EU) 2018/1139 and (EU) 2019/2144 and Directives 2014/90/EU, (EU) 2016/797 and (EU) 2020/1828 (Artificial Intelligence Act)
  • BS ISO/IEC 5259-5:2025: Artificial intelligence. Data quality for analytics and machine learning (ML) — Data quality governance framework
  • Software and AI as a medical device: Software and artificial intelligence (AI) as a medical device: Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD)
  • PD CEN/CLC/TR 17894:2024: Artificial Intelligence. Artificial Intelligence Conformity Assessment
  • IMDRF/AIML WG/N88 FINAL 2025: Good machine learning practice for medical device development: Guiding principles
  • MDCG 2021-17: Applied-for scope of designation and notification of a conformity assessment body. Regulation (EU) 2017/745 (MDR)

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