AI-enabled medical devices in Europe sit across two regulatory frameworks: the Medical Device Regulation (MDR), which governs safety, performance, clinical evidence, and post-market surveillance, and the EU AI Act, which adds requirements for applicable AI systems.
Grayde.ai, a life science and healthcare AI data company, today released Navigating the EU MDR and AI Act: A Data-to-Deployment Guide for AI-Enabled Medical Devices.
The two frameworks, Medical Device Regulation (MDR) and EU AI Act, are often treated as separate workstreams, run by separate teams on separate timelines. But they draw on the same underlying evidence.
The guide maps how the two frameworks connect, showing where a single decision, such as how a dataset is documented or how model drift is monitored, feeds evidence for both.
What the guide covers
- A clear way to determine if your AI medical device falls under the MDR, the AI Act, or both
- The EU AI Act timeline and the deadlines medical-device AI teams need to prepare for
- How to build a traceable dataset with documented sources, labels, quality checks, and version history
- How to test for bias, subgroup performance gaps, data leakage, and language-related risk
- The evidence needed to move from model accuracy to clinical validation, documentation, and post-market monitoring
- Two worked case studies: one on classification and evidence pathways, and one on a high-performing model with weak dataset representativeness
“Strong model performance alone does not prove that an AI medical device is ready for regulatory review,” said Nikita Agarwal, Founder of Grayde.ai. “Teams must connect their intended purpose to the right patient data, labels, validation evidence, clinical claims, and post-market controls. This guide shows how to build that evidence chain from the start.”
What is included
The 34-page guide includes a regulatory applicability framework, guidance on annotation and ground-truth documentation, validation principles, post-market monitoring considerations, and two illustrative case studies.
It draws on the MDR, the EU AI Act, MDCG 2025-6 / AIB 2025-1 guidance on the interaction between the regulations, and current European Commission guidance. It is intended for educational purposes and does not constitute legal, regulatory, clinical, or notified-body advice.
How to download it
Navigating the EU MDR and AI Act: A Data-to-Deployment Guide for AI-Enabled Medical Devices is available now to download on Grayde.ai’s website.
Grayde.ai builds regulatory-ready training data and expert evaluation for AI-enabled healthcare systems. Every annotation, evaluation, and review is produced by a credentialed life science specialist, fully attributed, and documented to the standard regulated submissions require. The company serves medical AI labs, SaMD developers, and pharma AI teams.
