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AI & MDR/IVDR Device Regulatory Pathway Tool
AI & MDR/IVDR DEVICE REGULATORY PATHWAY TOOL
The AI & MDR/IVDR Device Regulatory Pathway provides manufacturers with a comprehensive overview of the key steps to consider when developing and placing an AI-enabled medical device on the EU market in Finland. The pathway brings together essential aspects of MDR/IVDR requirements and the AI Act, covering topics such as intended purpose, risk classification, quality management, assessments, conformity, and post-market surveillance.
The purpose of this tool is to support manufacturers in planning and managing their regulatory activities. It is intended for informational purposes only and does not constitute legal advice or replace a device-specific regulatory assessment. Manufacturers should always carefully review the applicable legislation, guidance documents, and requirements relevant to their specific device. Responsibility for regulatory compliance and meeting all applicable requirements remains with the manufacturer.
The Regulatory Pathway Tool has been developed in collaboration with leading experts in AI and MDR/IVDR regulation.
The content is based on information available on 1 May 2026 regarding the EU AI Act, the Medical Devices Regulation (MDR), and the In Vitro Diagnostic Medical Devices Regulation (IVDR).
Last updated: 4 May 2026.
