AI strategy for MedTech. Navigate dual compliance: EU AI Act × MDR.

1. Dual compliance obligation: EU AI Act + MDR creates complex compliance requirements. MDCG 2025-6 provides guidance but every AI update can require a new conformity pathway. The agile update model of software clashes with the static certification model of MDR.

2. Software as Medical Device (SaMD): AI algorithms in medical devices must be MDR-certified. Every significant update potentially requires recertification. This slows innovation unless governance-by-design is implemented.

3. Bias mitigation: EU AI Act explicitly requires bias mitigation in high-risk medical AI. This must be integrated into the Quality Management System — not as a separate exercise but as part of product development.

4. Interoperability: Medical AI must integrate seamlessly with diverse EHR systems. HL7 FHIR compliance and standardisation are prerequisites for market acceptance and clinical adoption.

The publication of MDCG 2025-6 marks a significant moment for the MedTech sector. For the first time, European authorities provide concrete guidance on the interaction between the EU AI Act and the Medical Device Regulation. The proposal to integrate conformity assessments — one assessment covering both frameworks — is positive.

But the reality is more complex. Every significant AI update can trigger a new conformity pathway under MDR. The agile update model of software development clashes directly with the static certification model of medical devices. Governance-by-design — building compliance into the development process itself — is the only scalable solution.

MedTech companies that implement this first are building not only regulatory advantage, but also market trust among hospitals and clinicians who are increasingly scrutinising the governance of AI in their clinical workflows.

AlphaIndigo practitioners combine sector experience in healthcare and life sciences with certified AI governance expertise. Our team operates as embedded leaders — not external advisers who leave reports behind.

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