New labeling obligations under the MDR

Compared to the MDD 93/42/EEC, the new Medical Devices Regulation EU 2017/745 (MDR) sets out additional requirements manufacturers need to adhere to for device labeling. According to Art. 2 of the MDR, a label is “the written, printed or graphic information appearing either on the device itself or on the packaging of each unit or on the packaging of multiple devices”.

Chapter III of Annex I clarifies that the information accompanying the device (label and instructions for use) is meant to identify the medical device and its manufacturer, as well as . . .


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