Medical Devices Ordinance
(MedDO)

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 safe and ef­fect­ive by means of a risk ana­lys­is and val­id­a­tion pro­cess;

b.

op­er­ate a qual­ity man­age­ment sys­tem that is both suit­able and cer­ti­fied to na­tion­ally or in­ter­na­tion­ally re­cog­nised stand­ards;

c.

provide proof that re­pro­cessing takes place in suit­able premises, in ac­cord­ance with the re­cog­nised rules of sci­ence and tech­no­logy and in com­pli­ance with hy­giene re­quire­ments.

d.

doc­u­ment that the device has been re­pro­cessed in ac­cord­ance with let­ter a.

⁴ The de­clar­a­tion re­quired un­der para­graph 3 let­ter a must identi­fy the device and state the name and ad­dress of the es­tab­lish­ment that re­pro­cessed it.