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Art. 8 Specific requirements
1 Devices without an intended medical purpose in accordance with Article 1 paragraph 1 letter b must comply with the common specifications stipulated by Swissmedic. 2 Devices that have both a medical and non-medical intended purpose must fulfil both the requirements for devices with an intended medical purpose and the requirements for devices without an intended medical purpose. 3 Devices that are also machines within the meaning of Article 1 of the Machine Ordinance of 2 April 200825 must satisfy the pertinent general safety and health protection requirements of the Machine Ordinance where these requirements are more specific than those of Chapter II of Annex I to EU-MDR26. |