MDR
Medical Device Regulation (EU) 2017/745
Compliance with Medical Device Regulations
Lymed products comply with the requirements of the EU Medical Device Regulation (EU) 2017/745 (MDR). Our product range also includes wellness products that are not classified as medical devices.
Standard Products
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CE-marked Class I medical devices
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designed for general use with standard sizing
Custom-Made Products
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Class I custom-made medical devices
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designed and manufactured based on the user’s individual measurements and needs
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manufactured, where applicable, in accordance with the guidance or prescription of a healthcare professional
In Finland, medical devices are supervised by Fimea (Finnish Medicines Agency).