Reg­u­la­tions (EU) 2017/745 and 2017//46 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) clear­ly require that man­u­fac­tur­ers must trans­late labels and instruc­tions for use (IFU) accord­ing to nation­al mar­ket pro­vi­sions. The lat­ter point was often per­ceived a chal­lenge as clear guid­ance which mar­kets require trans­la­tions was not acces­si­ble easily. 

The Euro­pean Com­mis­sion pro­vid­ed tab­u­lar overviews regard­ing the lan­guage require­ments in dif­fer­ent mem­ber coun­tries for the MDR and the IVDR. The tables refer to spe­cif­ic pro­vi­sions for labels and IFU, implant cards, dec­la­ra­tions of con­for­mi­ty, field safe­ty notices, doc­u­ments for con­for­mi­ty assess­ment and graph­i­cal user inter­faces, e.g. in apps.

It is note­wor­thy that the doc­u­ments say the Com­mis­sion does not take respon­si­bil­i­ty for the cor­rect­ness of the includ­ed infor­ma­tion and that legal pro­vi­sions take prece­dence over the infor­ma­tion in the tables. We thus think man­u­fac­tur­ers should still screen avail­able infor­ma­tion on lan­guage trans­la­tions, but the two tables give a good overview of the cur­rent status.

Please let us know should you wish mdi Europa to send the cor­re­spond­ing doc­u­ments to you.

You can find the files in our library of down­load them here: 

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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