Clinical Evidence: The device master file should contain the Clinical Evidence, Evaluation report that demonstrates conformity of the in vitro diagnostic medical device to the Essential Principles that apply to it. 20.0 Labelling: The device master file should typically contain a complete set of labeling associated with the in vitro medical device as described in Chapter VI. 21.0 Post marketing surveillance data (vigilance reporting): The dossier should contain the post marketing surveillance or vigilance reporting procedures and data collected by the manufacturer encompassing the details of the complaints received and corrective and preventive actions taken for the same.