Medical Devices Ordinance
(MedDO)

¹ A device may be placed on the mar­ket or put in­to ser­vice only if it com­plies with this Or­din­ance when duly sup­plied and prop­erly in­stalled, main­tained and used in ac­cord­ance with its in­ten­ded pur­pose.

² Devices must con­form to the gen­er­al safety and per­form­ance re­quire­ments set out in An­nex I to EU-MDR¹⁰, tak­ing ac­count of their in­ten­ded pur­pose.

³ Ap­pro­pri­ate evid­ence that the part of the com­bin­a­tion that is deemed to be a device un­der the cases set out in Art­icle 2 let­ters f–h ful­fils the product re­quire­ments must be presen­ted to the com­pet­ent au­thor­ity on de­mand.

⁴ Com­pli­ance with the es­sen­tial re­quire­ments of this Or­din­ance, as covered by des­ig­nated tech­nic­al stand­ards¹¹, com­mon spe­cific­a­tions or pre­scrip­tions of the phar­ma­co­poeia¹², is pre­sumed if the device is in con­form­ity with these stand­ards, spe­cific­a­tions or pre­scrip­tions.

⁵ The pre­sump­tion made in para­graph 4 also ap­plies to com­pli­ance with the sys­tem or pro­cess re­quire­ments that eco­nom­ic op­er­at­ors must com­ply with un­der this Or­din­ance, in­clud­ing re­quire­ments as­so­ci­ated with qual­ity man­age­ment sys­tems, risk man­age­ment, post-mar­ket sur­veil­lance sys­tems, clin­ic­al tri­als, clin­ic­al eval­u­ation or post-mar­ket clin­ic­al fol­low-up.

⁶ Com­pli­ance with the com­mon spe­cific­a­tions in para­graph 4 is re­quired un­less the man­u­fac­turer can provide ap­pro­pri­ate proof that the solu­tions it has chosen guar­an­tee equi­val­ent con­form­ity with the safety and per­form­ance re­quire­ments. The above is sub­ject to Art­icle 8 para­graph 1.