English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 61 Supply
1 Devices are supplied in accordance with their intended purpose and the information provided by the manufacturer. 2 Devices for self-testing may be supplied only if the dispensing point can guarantee that professional advice is available and that the operational requirements are satisfied. Article 13 of the Federal Act of 15 June 2018 on Human Genetic Testing also applies. 3 Dispensing devices for the diagnosis of human communicable diseases to the general public is prohibited. Swissmedic may approve exceptions in the interests of public health.
Para. 2 — SR 810.12 Para. 2 — Amended by Annex No 2 of the O of 29 Sept. 2023, in force since 1 Nov. 2023 (AS 2023 576).
Art. 62 Advertising
1 Claims for devices must only contain statements that correspond to the product information. 2 Misleading statements, particularly concerning the intended purpose, safety and performance of a device, are prohibited. 3 Devices intended solely for use by healthcare professionals must not be advertised to the public.
Art. 63 Use
Any professional who uses a device from a foreign country directly without placing it on the market is responsible for the conformity of that device.
Art. 64 Maintenance
1 Any professional using devices must ensure that the devices are maintained and tested in accordance with the regulations. 2 Maintenance must be carried out in accordance with the principles of a quality management system, is to be organised appropriately, and must be guided in particular by: a. the manufacturer's instructions; b. the particular risk associated with the device and its use. 3 For devices with a measurement function, test procedures may be required in accordance with the Measuring Instruments Ordinance of 15 February 2006. 4 Swissmedic may issue and publish requirements for maintenance measures. These requirements shall be deemed to constitute the current scientific and technological standards.
Para. 3 — SR 941.210
Art. 65 Cyber security
1 Healthcare institutions must put in place all technical and organisational resources required by the state of the art to ensure that network-compatible devices are protected against electronic attack and unauthorised access. 2 Hospitals must identify, evaluate and document the measures taken under paragraph 1 in accordance with the principles of a risk management system. This system forms an integral part of the hospitals’ quality management system.
