Medical Device Regulation (EU) 2017/745
Lymed products meet the general safety and performance requirements of the regulation and Lymed Oy meets the requirements of the regulation.
The regulation of medical devices has changed. The new Medical Devices Regulation (EU) 2017/745 (MDR) replaces Directive MDD 93/42 / EEC on medical devices.
The MDR introduces new classification rules that require manufacturers to determine the risk category of their equipment. In order to classify a device in accordance with the MDR, the intended use of the device and the risks inherent in it must be taken into account.
Lymed standard size standard products: Class 1 medical device
The device shall meet all applicable general safety and performance requirements of Annex I to the MDR. The device must be accompanied by information on the safety and performance of the device (markings, device packaging and operating instructions). The device must bear the CE marking in accordance with Annex V of the MDR. Lymed standard size standard products come with a CE-marked packaging label and instructions for use.
Lymed custom products: Custom-made device
Custom device means a device intended exclusively for use by a specific patient, meeting his individual requirements and needs, specially manufactured in accordance with a written order issued by a person authorized to do so under national law and under the responsibility of that person. Lymed custom-made products come with a packaging label and instructions for use.
Fimea monitors the compliance of medical devices and industry in Finland. Conformity control of devices applies to medical devices placed on the market and their professional use and maintenance. More information: https://www.fimea.fi/laakinnallinen_laitteet