Medical Devices Ordinance
(MedDO)

¹ If the ap­plic­able con­form­ity as­sess­ment pro­ced­ure has demon­strated that the re­quire­ments of this Or­din­ance have been ful­filled, the man­u­fac­turer of devices that are not cus­tom-made or in­vest­ig­a­tion­al is­sues a de­clar­a­tion of con­form­ity. The man­u­fac­turer shall con­tinu­ously up­date this de­clar­a­tion.

² The de­clar­a­tion of con­form­ity shall in­clude the in­form­a­tion re­quired in An­nex IV to EU-MDR⁶⁸, tak­ing ac­count of the amend­ments to this An­nex ad­op­ted by the European Com­mis­sion by means of del­eg­ated acts⁶⁹. It must be writ­ten in one of the three of­fi­cial lan­guages of Switzer­land or Eng­lish or trans­lated in­to one of these lan­guages.

³ If a device also re­quires a man­u­fac­turer's de­clar­a­tion of con­form­ity for as­pects not covered by this Or­din­ance but nev­er­the­less re­quired by oth­er le­gis­la­tion in or­der to demon­strate com­pli­ance with that le­gis­la­tion, a single de­clar­a­tion of con­form­ity shall be drawn up.

⁴ By draw­ing up the de­clar­a­tion of con­form­ity, the man­u­fac­turer as­sumes re­spons­ib­il­ity for com­pli­ance with the re­quire­ments of this Or­din­ance and all oth­er le­gis­la­tion ap­plic­able to the device.