Product Specification: The dossier should contain a list of the features, dimensions and performance attributes of the medical device, its variants and accessories, that would typically appear in the product specification made available to the end user, e.g. in brochures, catalogues etc. 2.3 Reference to predicate or previous generations of the device: Where relevant to demonstrating conformity to the essential principles, and to the provision of general background information, the dossier should contain an overview of: (a) the manufacturer's previous generation of the device, if such exist; (b) predicate devices available on the local and international markets; and (c) comparative analysis to prove substantial equivalence to the predicate device(s) as claimed. 3.0 Labelling: The dossier should typically contain a complete set of labeling associated with the device as per the requirements of Chapter VI of these rules. Information on labelling should include the following:— (a) Copy of original label of the device, including accessories if any, and its packaging configuration; 45[(b) Instructions for use or electronic instructions for use (Prescriber's manual);] (c) Product brochure; and (d) Promotional material.