Artificial Intelligence (AI) is transforming medical devices—from diagnostic algorithms to adaptive therapeutic systems. But bringing an AI-enabled medical device to market in the EU demands more than software development. You must align with the MDR (EU 2017/745), emerging AI regulation, data-governance standards, cybersecurity requirements and ensure that patient data used for development is handled properly.
At MDS, we help manufacturers navigate this complex landscape—ensuring that your AI-based device is not only innovative, but also regulator-ready, secure, and aligned with state-of-the-art requirements.
AI in Medical Devices: What’s Special?
Manufacturers of AI-powered medical devices face overlapping regulatory requirements:
-
The MDR classifies software as a medical device (MDSW) when it has a medical purpose.
-
The emerging Artificial Intelligence Act (AI Act) places additional obligations on high-risk AI systems (which many AI medical devices will qualify as).
-
The joint guidance from Medical Device Coordination Group (MDCG 2025-6) confirms that AI medical devices must comply both with MDR and AI Act obligations.
Because AI systems often rely on large datasets, learning models, and ongoing updates, the datasheet, data governance, traceability, cybersecurity and lifecycle monitoring become critical.
Data Use & Anonymization: Why It Matters
When patient data is used for training and validating AI models, the EU expects robust governance:
-
GDPR implications: If data is identifiable or re-identifiable, GDPR applies. Pseudonymization or anonymization must follow best practices so that individuals cannot be identified.
-
Dataset traceability and quality: AI-led devices must document dataset demographics, representation, bias assessment, missing data and data drift.
-
Documentation of data provenance, preprocessing and updates: The AI Act requires detailed technical documentation of datasets, training processes, model architecture, test/validation datasets and performance metrics.
-
Ongoing monitoring of real-world performance: Because AI models may degrade over time (due to data drift or new populations), post-market performance monitoring is essential.
For manufacturers, this means building data governance into your quality system from day one, documenting how data is collected, anonymized/pseudonymized, validated, and how models are maintained.
Cybersecurity & Software-as-Medical-Device Requirements
AI medical devices are software systems with significant cybersecurity and software lifecycle demands. Under the MDR and related guidance:
-
Cybersecurity is explicitly addressed in Annex I (GSPR) of the MDR and in guidance documents.
-
The AI Act further emphasises robustness, human oversight, transparency, and logging for high-risk AI systems.
-
Products with digital elements may also be subject to the Cyber Resilience Act (CRA) — requiring incident reporting, lifecycle support and secure software updates.
For an AI medical device this means: develop a software lifecycle process (per IEC 62304), secure the model/data chain, document versioning, maintain logs, plan for updates, manage cybersecurity incidents, perform risk management (including bias/robustness/attack resistance) and integrate all into your QMS.
How MDS Supports Your AI Medical Device Journey
With our full-service offering across regulatory, clinical and technical domains, we help you bring AI-enabled devices to market in the EU:
-
Regulatory strategy & classification: We help determine how MDR, AI Act and related legislation apply to your product.
-
Technical file preparation: Our experts compile all required documentation — device description, software architecture, dataset governance documents, verification/validation reports, risk management (including bias/robustness analysis).
-
Clinical evaluation & performance evidence: We assist with CEP and CER development, ensuring your data supports claimed performance and safety.
-
Data governance & anonymization review: We evaluate your data sourcing and processing strategies, assess pseudonymization/anonymization, dataset representativity and bias mitigation.
-
Cybersecurity & software lifecycle support: We integrate cybersecurity, version control, update strategy, incident handling and change management into your documentation and QMS.
-
Post-market monitoring & verification: We help design ongoing performance monitoring, change-control plans, documentation updates and integration into your technical file and CER.
Bringing It All Together
AI gives medical devices unmatched power to transform care—but only if they are built and documented with regulatory rigor. Manufacturers that treat data governance, model lifecycle, cybersecurity and clinical evidence as integral from the start gain a competitive advantage.
At MDS we support your journey from concept to CE mark and beyond—providing the regulatory, clinical and technical backbone for your AI medical device.
📩 Interested in discussing your AI medical device strategy? Contact us at sales@mdsfinland.com or schedule a consultation via Book a Meeting.
