On November 21, 2022, the MDA has announced the release of the Sixth Edition Guidance Document “Requirements for Labelling of Medical Devices” (MDA/GD/0026). This guidance document provides minor updates from the Fifth Edition that was issued on 14 June 2022. This document provides guidance to the manufacturers and authorized representatives on the content of medical device labelling.
The minor update was focused on clarifying clause 4.8.1:
“The label of a medical device shall contain the following information: the details strictly necessary for a user to identify the device, the contents of the packaging and, where it is not obvious for the user, the intended purpose of the device”.
Further information on Sixth Edition Guidance Document “Requirements for Labelling of Medical Devices” (MDA/GD/0026), please refer to this link.
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