List of applied standards and common specificationsīenefit-risk analysis and risk management Systematic evidence of compliance with the General Safety and Performance Requirements General Safety and Performance Requirements Quality assurance agreements with subcontractors for outsourced production steps and in the case of sterile devices for outsourcing of packaging and/or sterilisation Overview in tabular format of outsourced processes and name/address of the executing companiesĮvidence of qualification of subcontractors Information on controlled conditions under which certain manufacturing steps take place Information on specific processes and their validation Identification of all sites where design processes were performedĬomprehensible description of manufacturingĪddresses of all manufacturing sites with information on the manufacturing steps Overview of the similar generation(s) of the device available on the market in the European Union or on international marketsĮuropean Authorized Representative valid agreement and disply of name and contact information in technicla file and information panels.ĭescription of the applied design process Overview of the previous generation(s) of the device produced by the manufacturer Identification of substances that come into direct or indirect contact with the human bodyįormal statement in a separate document if the device is manufactured utilizing tissues or cells of human origin, or their derivativesįormal statement in a separate document if the device is manufactured utilizing tissues or cells of animal origin, or their derivativesįormal statement in a separate document if the device incorporates, as an integral part, a substance which, if used separately, may be considered to be a medicinal product within the meaning of point 2 of Article 1 of Directive 2001/83/EC, including a medicinal product derived from human blood or human plasma, as referred to in the first subparagraph of Article 1(8) Specifications of packaging materials (primary and secondary packaging)Ĭertificates of analysis from the suppliers Specifications of raw materials components/subassemblies Overview of all raw materials, components, packaging materials Raw materials, components, packaging materials Summary of safety and clinical performance Variants/components/configurations and accessories of the deviceĮxplanations of new characteristics and new intended purposes/indicationsĭescription of the principles of operation of the device and its mode of action UMDNS/GMDN classification (if applicable) Overview of devices/ device groups/device typesĪll trade names under which the device is placed on the market General description of the device, its variants and its intended purpose
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