Coun­cil of the Euro­pean Union pro­pos­es key ele­ments for MDR/ IVDR reform

It is hot­ly debat­ed that Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devise and in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) urgent­ly need to be revised. Dif­fer­ent time­lines and focus points are cur­rent­ly dis­cussed for the revi­sion of the regulations. 

The Coun­cil of the Euro­pean Union issued a joint paper on Novem­ber 28 ini­ti­at­ed by Croa­t­ia, Fin­land, France, Ger­many, Ire­land, Lux­em­bourg, Roma­nia, Mal­ta and Slove­nia. The paper pro­pos­es nec­es­sary reforms in the MDR and IVDR and gives its view on pri­or­i­ties and main points. These are:

• Reduc­tion of admin­is­tra­tive oblig­a­tions of stakeholders
• Cen­tral­i­sa­tion of sys­tem man­age­ment func­tions to the EMA
• Fore­see­able and bal­anced cer­ti­fi­ca­tion procedures
• Tak­ing into account spe­cif­ic needs for med­ical devices intend­ed for spe­cif­ic patient populations
• Assur­ing a spe­cial path­way for innovations

In the pre­vi­ous months, espe­cial­ly pro­pos­als brought for­ward by Par­lia­ment made the head­lines. We will keep you updat­ed about any new devel­op­ments or deci­sions in that regard. The doc­u­ment can be accessed here.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Euro­pean Par­lia­ment ini­tia­tive for MDR improvement
• EU Arti­fi­cial Intel­li­gence Act final text agreed to by Par­lia­ment Committees