Regulatory Intelligence Pack: AI in MedTech

English

Use of AI in medical technologies is moving fast. Regulation is catching up. Understanding how AI regulations interact with medical device regulatory frameworks is no longer optional, it’s critical for compliance and strategy.

Instead of purchasing individual articles, get a curated set of high-impact AI insights, written by AI medical technology experts, designed to give you the complete picture.

 

What’s inside the Regulatory Intelligence Pack – AI in MedTech?

• The many ambiguities of the EU AI Act: Navigate the regulatory complexities of AI-powered medical devices and understand the implications for high-risk systems (May 2025)
• AI in literature screening: How AI tools can streamline clinical evaluation while staying compliant with MEDDEV requirements (May 2026)
• Levels of autonomy in medical AI: Analysis of autonomous medical AI, exploring regulatory challenges, risk management, and how emerging AI technologies may reshape clinical practice and healthcare delivery (February 2026)
• Clinical data and the federated learning concept for an AI/ML device: Understand how federated learning could be used to train AI/ML medical devices while protecting patients’ health data (February 2025)

 

About the authors:

Cécile van der Heijden
Senior attorney-at-law at Axon Lawyers
She specialises in the intersection between data protection and medical technology. Her expertise includes the GDPR, MDR, IVDR, European Health Data Space Act and the AI Act as well as clinical research with medical devices. Cécile partners with medical technology companies to seamlessly navigate complex legal landscapes, enabling them to innovate confidently while maintaining compliance with regulatory frameworks.

Sara VanWyk, MPH, CCRP, RAC-Devices, MWC
Principal Medical Writer at Arthrex, Inc.
She has 10 years of experience in writing for compliance with the EU Medical Device Directive 93/42/EEC and Regulation (EU) 2017/745. Her area of expertise includes drafting clinical evaluation plans and reports.

Anthony N. Khoury, PhD
Senior Scientific Specialist at Arthrex, Inc.
He provides expert scientific guidance and technical support for biomechanical engineering and clinical research studies. He also contributes to strategic research and regulatory initiatives that are critical to new product development and the safety and efficacy of orthopaedic medical devices.

Elaine Schmidt, MSc, MWC
Senior Medical Writer at Arthrex, Inc.
She has more than five years of experience in writing for compliance with the EU Medical Device Directive 93/42/EEC and Regulation (EU) 2017/745 and conducting systematic literature reviews for clinical evaluation plans and reports.

Abhineet Johri
He has more than 21 years of experience in the software medical device industry. His prior and current experience includes quality management, product risk management, complaints management and regulatory affairs. He is a consultant on processes and requirements for conducting clinical investigations/multi-reader studies for AI based devices, and has developed strategies to clear AI based medical devices in various countries around the globe. He is a published author, and a senior key expert for various regulatory processes within his organisation including AI/ML based devices. He is also a member of, and contributor to, various industry associations and AI committees such as the Medical Imaging & Technology Alliance (MITA) / MDCI and International Electrotechnical Commission sub-committees (USNC TAG to IEC SC 62B and expert on IEC SC 62B/PT 63524).

Arisha Johri
A high-achieving high school junior with a strong passion for healthcare, medical research, and community service. She is the founder of the HOSA – Future Health Professionals chapter at New Albany Schools, where she leads students interested in pursuing careers in medicine and health sciences. Arisha also serves as the Program Director for Youth Programs at the Columbus Vedic Society, designing educational and cultural initiatives that support leadership, values, and community connection among young students. She works part-time as an Events and Programs Specialist in the Memory Care department of a nursing home, providing compassionate, hands-on support to elderly residents with dementia and Alzheimer’s disease – experience that has deepened her dedication to the medical field. Alongside her leadership roles, Arisha engages in extensive volunteering efforts serving vulnerable populations, including seniors, underserved families, and children. Arisha is currently involved in research projects relating to gene therapy and other health-focused topics, further expanding her understanding of scientific inquiry and the future of medicine.

 

All of these articles have been published previously in the Journal of Medical Device Regulation. They are also for sale individually through our Software, AI and Digital Health Regulatory Knowledge Hub.