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)


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Art. 28 Documentation requirements

1 The des­ig­nated body will provide Swiss­med­ic and the oth­er des­ig­nated bod­ies with:42

a.
all in­form­a­tion on cer­ti­fic­ates it has is­sued and any amend­ments or ad­denda to such cer­ti­fic­ates;
b.
in­form­a­tion on sus­pen­ded, re­act­iv­ated or re­voked cer­ti­fic­ates;
c.
in­form­a­tion on cer­ti­fic­ates it has re­jec­ted;
d.
in­form­a­tion on re­stric­tions im­posed on cer­ti­fic­ates.

2 It will also provide Swiss­med­ic with in­form­a­tion on wheth­er or not a con­form­ity as­sess­ment pro­ced­ure should be ap­plied in ac­cord­ance with Art­icle 54 para­graph 1 EU-MDR43. No­ti­fic­a­tions of cer­ti­fic­ates for devices that have un­der­gone a pro­ced­ure of this type must in­clude the doc­u­ments spe­cified in Art­icle 55 para­graph 1 EU-MDR.44

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

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

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

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