Medical Devices Ordinance (MedDO) (MedDO)
English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.
Art. 68 Supply
Devices are supplied in accordance with their intended purpose and the information provided by the manufacturer.
Art. 69 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.
Para. 3 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
Art. 70 Application
1 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. 2 Device groups intended for use by healthcare professionals and which could harm the health of humans in the case of improper use are listed in Annex 6. 3 The groups of devices in Annex 6 may only be used in accordance with the professional and operating requirements stated therein.
Art. 70 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291). Para. 2 — Amended by Annex 5 No 1 of the O of 4 May 2022 on In Vitro Diagnostic Medical Devices, in force since 26 May 2022 (AS 2022 291).
Art. 71 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. 72 Reprocessing
1 Any person using in a professional capacity a device intended for repeated use must ensure on each occasion and prior to use that its functionality has been tested and that it has been reprocessed in accordance with current scientific and technological standards and taking account of the instructions of the manufacturer and the requirements of hygiene. 2 Reprocessing must employ suitable procedures that have been validated in accordance with current scientific and technological standards and whose efficacy has been demonstrated and can be reliably traced and reproduced within a quality management system. 3 Any natural or legal person who reprocesses devices for third parties must: a. declare that the reprocessed device: 1. has been reprocessed in accordance with the manufacturer’s instructions, or 2. has been reprocessed using a procedure specific to the processor that is equally safe and effective as the procedure specified by the manufacturer and has been demonstrated to be equally
Art. 73 Single-use devices and their reprocessing
1 Reprocessing and further use of single-use devices is forbidden. 2 Single-use devices reprocessed in a foreign country under Article 17 paragraph 3 EU-MDR must neither be used nor made available on the market.
Para. 2 — See the footnote to Art. 4 para. 1 let. f.
Art. 74 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.
