Due to some promi­nent med­ical device scan­dals in the past years, the Euro­pean Com­mis­sion intro­duced the MDR and IVDR with much stricter pro­vi­sions in May 2017. mdi Europa intro­duces you to all rel­e­vant information.

To find out more about the MDR / IVDR sub­ject, use the fol­low­ing links 

MDR – Med­ical Devices Reg­u­la­tion (EU) 2017/745

REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on med­ical devices, amend­ing Direc­tive 2001/83/EC, Reg­u­la­tion (EC) No 178/2002 and Reg­u­la­tion (EC) No 1223/2009 and repeal­ing Coun­cil Direc­tives 90/385/EEC and 93/42/EEC.

Vis­it page “MDR” on mdi Europa.
Browse all arti­cles regard­ing the MDR by key­word.

IVDR – In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (EU) 2017/746

REGULATION (EU) 2017/746 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 5 April 2017 on in vit­ro diag­nos­tic med­ical devices and repeal­ing Direc­tive 98/79/EC and Com­mis­sion Deci­sion 2010/227/EU.

Vis­it page “IVDR” on mdi Europa.
Browse all arti­cles regard­ing the IVDR by key­word.