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Showing 1 to 1 of 1 for “"Annex XVI"”.
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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
This thesis examines the implementation of Annex XVI of the Medical device regulation (EU) 2017/745 (MDR) in Finland. Annex XVI extends the MDR’s scope to include products without an intended medical purpose, such as dermal filler and intense pulsed light (IPL) devices, which have similar risk …