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Edita Mutaku

Senior Inspector
Finnish Medicines Agency FIMEA
Finland

I work as a Senior Inspector at the Finnish competent authority for medical devices, the Finnish Medicines Agency (Fimea). I am part of the Market Surveillance section, where my responsibilities include inspecting IVD and MD manufacturers and other economic operators, performing market surveillance tasks, and collaboration with both national and international authorities, including at the EU level. Before joining Fimea, I worked as a Regulatory Affairs Manager for an IVD manufacturer, where I gained extensive experience in regulatory and quality management matters. My academic background is in biochemistry, and I have also worked as a project researcher in synthetic biology.

Topics

Regulatory Landscape in 2026: Competent Authority Perspectives on MDR and IVDR

Developing Health Technology
Regulatory Landscape
5.2.2026 11:20 - 12:00 | Hall 205

This presentation provides an overview of key regulatory developments from the competent authority’s perspective. It covers upcoming timelines regarding IVDR and MDR, targeted revision of the EU rules for medical devices and in vitro diagnostics, enhanced EU-level cooperation through initiatives and insights from 2025 market surveillance activities. Additional topics include new horizontal legislation impacting the sector, including the AI Act and NIS2 Directive.