Medical Devices Ordinance
(MedDO)

¹ For class III devices and for im­plant­able devices, oth­er than cus­tom-made or in­vest­ig­a­tion­al devices, the man­u­fac­turer must draw up a sum­mary of safety and clin­ic­al per­form­ance.

² The sum­mary of safety and clin­ic­al per­form­ance shall be writ­ten in a way that is clear to the in­ten­ded user and, if rel­ev­ant, to the pa­tient.

³ The min­im­um con­tent of the sum­mary is gov­erned by Art­icle 32, Para­graph 32 EU-MDR¹⁰¹.

⁴ The draft sum­mary must be sub­mit­ted, to­geth­er with the doc­u­ment­a­tion, to the des­ig­nated body in­volved in the con­form­ity as­sess­ment for val­id­a­tion by that body.¹⁰²

⁵ The man­u­fac­turer shall pub­lish the sum­mary after it has been val­id­ated.¹⁰³

⁶ The man­u­fac­turer must men­tion on the la­bel or in­struc­tions for use where the sum­mary is avail­able.