Medical Devices Ordinance
(MedDO)

English is not an official language of the Swiss Confederation. This translation is provided for information purposes only and has no legal force.

of 1 July 2020 (Status as of 26 May 2021)


Open article in different language:  DE  |  FR  |  IT
Art. 63

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-MDR75.

4 The draft sum­mary of safety and clin­ic­al per­form­ance must be sub­mit­ted to the des­ig­nated body in­volved in the con­form­ity as­sess­ment pur­su­ant to Art­icle 24 for val­id­a­tion by that body.

5 The man­u­fac­turer will pub­lish the sum­mary after it has been val­id­ated.76

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

75 See the foot­note to Art. 4 para. 1 let. f.

76 Amended by No I of the O of 19 May 2021, in force since 26 May 2021 (AS 2021 281).

Previous article Show article in the law Next article

Diese Seite ist durch reCAPTCHA geschützt und die Google Datenschutzrichtlinie und Nutzungsbedingungen gelten.

Feedback
Gesetzeskürzel Name
DE FR IT EN
DE FR IT EN
Laden