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Showing 1 to 1 of 1 for “"Fimea"”.
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Stakeholder Landscape and Regulatory Implementation of Annex XVI Products in Finland: Oversight of Medical Devices Without an Intended Medical Purpose with Reference to the European Context
… in the implementation in Finland, including Fimea, Tukes and STUK. The study explores how these actors interpret their roles and responsibilities under the MDR framework, what challenges they face in implementation, and how Finland’s approach compares with that of other European countries. …