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1. General requirements for the products and compliance Legal compliance: All offered medical devices must comply with the requirements of the Medical Devices Act (ZMI) and with Regulation (EU) 2017/745 (MDR) on medical devices or equivalent. Conformity marking: All products must obligatorily have a valid “CE” marking applied to their packaging by the manufacturer or by its authorised representative. Quality management system: The manufacturer of the medical devices must have an implemented and certified quality management system in accordance with the international standard ISO 13485 (or equivalent) for design, development and manufacturing of medical devices. Conformity documents: For each lot/position, the participant must be able to submit a valid EU Declaration of Conformity issued by the manufacturer, proving compliance with the applicable legislation or equivalent. 2. General characteristics and requirements for materials Cotton, gauze and dressings (item 1-8, 15, 32): must be made of high-quality natural cotton, bleached perfectly without the use of chlorine or optical brighteners. They must not contain impurities, side chemicals or odour. They must have excellent…

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