(i) for medical devices intended to emit ionizing radiation, information on radiation source (e.g. radioisotopes) and the material used for shielding of unintended, stray or scattered radiation from patients, users and other persons shall be provided. 2.2 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.