Medical Devices Ordinance
(MedDO)


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Art. 60 Obligation

1 Man­u­fac­tur­ers of class IIa, class IIb and class III devices shall pre­pare a safety re­port for each device and where rel­ev­ant for each cat­egory or group of devices.

2 Man­u­fac­tur­ers of class IIa devices shall up­date the safety re­port when ne­ces­sary and at least every two years. Man­u­fac­tur­ers of class IIb and class III devices must up­date this re­port at least an­nu­ally.

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