System Quality:Risk Class I devices do not require an ISO 13485 quality management system but do require several procedures, i.e.Product Description and technical information:includes description and intended use model numbers and accessories, explanation of manufacturing process, design configuration and packaging information, etc.List of translation companies is provided. Manufacturer to arrange for translations of required documentation. EU States and languages:Identifying the EU states where the device(s) will be sold.Listing the device manufacturers suppliers and other third parties, defining the services and components they provide to the manufacturer, with copies of quality management certificates where available.Document organizing the devices into product categories and groups based on an EU harmonized standard prepared by consultant and completed by the manufacturer for each technical file.
Example of a typical guidance package addressing:
