The EU has approval to adopt and list stan­dards that will be recog­nised under Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR). The legal basis is now oper­a­tional for the EU to begin pub­li­ca­tion in the Offi­cial Jour­nal of the Euro­pean Union of ref­er­ences of har­monised stan­dards in the con­text of the MDR and IVDR, which are valid on 26 May this and next year, respectively.

The EU stan­dards organ­i­sa­tions, CEN and Cen­elec, con­sent­ed to the Euro­pean Commission’s man­date to revise about 200 exist­ing stan­dards that had been list­ed under the cur­rent med­ical devices direc­tives and draft 27 new stan­dards to give sup­port to the imple­men­ta­tion of the new reg­u­la­tions. This is a cru­cial step as har­monised stan­dards are an impor­tant means to demon­strate con­for­mi­ty with the MDR and IVDR gen­er­al safe­ty and per­for­mance requirements. 

Sources: Medtech Insight (an Infor­ma product)

For fur­ther in depth infor­ma­tion on this sub­ject we rec­om­mend the fol­low­ing arti­cles on our website