Ordinance
on Clinical Trials
with the exception of
Clinical Trials of Medical Devices1
(Clinical Trials Ordinance, ClinO)

1 Amended by Annex 2 No 2 of the O of 1 July 2020 on Clinical Trials of Medical Devices, in force since 26 May 2021 (AS 2020 3033).


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Art. 20 Categorisation of clinical trials of products under Article 2a paragraph 2 TPA 53

1 Clin­ic­al tri­als of products un­der Art­icle 2a para­graph 2 TPA come un­der Cat­egory A if:

a.
the product that is un­der in­vest­ig­a­tion has been no­ti­fied un­der Art­icle 6 para­graph 3 MedDO54 in its ver­sion of 1 Janu­ary 200255 in ap­plic­a­tion of Art­icle 108 para­graph 1 let­ter b MedDO; and
b.
it is used in ac­cord­ance with the in­struc­tions for use.

2 They come un­der Cat­egory C if:

a.
the product that is un­der in­vest­ig­a­tion has not been no­ti­fied un­der Art­icle 6 para­graph 3 MedDO in its ver­sion of 1 Janu­ary 2002 in ap­plic­a­tion of Art­icle 108 para­graph 1 let­ter b MedDO;
b.
the product that is un­der in­vest­ig­a­tion is not used in ac­cord­ance with the in­ten­ded pur­poses spe­cified in the in­struc­tions for use; or
c.
use of the product that is un­der in­vest­ig­a­tion is pro­hib­ited in Switzer­land.

53 Amended by An­nex 2 No 2 of the O of 4 May 2022, in force since 26 May 2022 (AS 2022 294).

54 SR 812.213

55 AS 2001 3487

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