Medical Devices Ordinance
(MedDO)


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Art. 14 Affixing conformity markings and identification numbers

1 The con­form­ity mark­ing and, where ne­ces­sary, the as­so­ci­ated iden­ti­fic­a­tion num­ber shall be af­fixed to the device it­self or its sterile pack­aging.

2 Where this is not pos­sible or prac­tic­able ow­ing to the nature of the device, the con­form­ity mark­ing and, where ne­ces­sary, the as­so­ci­ated iden­ti­fic­a­tion num­ber must be dis­played on the pack­aging.

3 The con­form­ity mark­ing shall also ap­pear in the in­struc­tions for use and on the sales pack­aging.

4 The re­quire­ments of Art­icle 20 para­graphs 3–6 EU-MDR35 and the gen­er­al prin­ciples of Art­icle 30 Reg­u­la­tion (EC) No. 765/200836 must also be ob­served when af­fix­ing the con­form­ity mark­ing.

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

36 Reg­u­la­tion (EC) No. 765/2008 of the European Par­lia­ment and of the Coun­cil of 9 Ju­ly 2008 set­ting out the re­quire­ments for ac­cred­it­a­tion and mar­ket sur­veil­lance re­lat­ing to the mar­ket­ing of products and re­peal­ing Reg­u­la­tion (EEC) No 339/93, last amended by OJ L 218 of 13.8.2008, p. 30.

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