A medical device label helps to identify the individual device and to communicate with the user about the safety and effectiveness of the device.
Where appropriate the labelling should use symbols and its additional explanation text should be include in information supplied by manufacturer complies with harmonised standard EN ISO 15223-1: 2012 . Apart from the points mentioned in MDD, MDR requires some more information to be included in the labels.
- The UDI (Unique Device Identification)carrier referred to in Article 27(4) and Part C of Annex VII; UDI must be registered in a database of EUDAMED.
- an indication that the device contains or incorporates: — a medicinal substance, including a human blood or plasma derivative as referred to in Regulation (EU) No 722/2012. Previously it was mentioned in IFU.
- for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number.
- the number of reprocessing cycles for single use device
MDR gives more importance to pre-clinical and clinical data for the safety and effectiveness of the medical device.
EU Medical Devices Regulation (MDR 2017/745) April 5, 2017.
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