We have screened the pub­li­ca­tions that were issued by the Euro­pean Com­mis­sion and oth­er orga­ni­za­tions over the past few weeks. Here are the most impor­tant items.

Noti­fied body stan­dard fees

The Euro­pean Com­mis­sion has issued a doc­u­ment that links to the cor­re­spond­ing web­sites of MDR and IVDR noti­fied bod­ies and their stan­dard fees. Com­mer­cial con­sid­er­a­tions are cru­cial when decid­ing which orga­ni­za­tion is engaged for con­for­mi­ty assess­ment. You may access the afore­men­tioned overview here.

eIFU

The Euro­pean Com­mis­sion has launched a sur­vey on the use of elec­tron­ic instruc­tions for use (eIFU) for pro­fes­sion­al users. The use of eIFU is strict­ly lim­it­ed in the Union, but stake­hold­ers argue that the sup­ply of hard copy ver­sions is out­dat­ed and not appro­pri­ate any­more for sev­er­al rea­sons. Stake­hold­ers now have the oppor­tu­ni­ty to influ­ence the debate and take part in the sur­vey, which is still open until Octo­ber 11, 2024.

Imple­ment­ing deci­sion for UDI designation

The Euro­pean Com­mis­sion has extend­ed the des­ig­na­tions of the UDI issu­ing agen­cies for five addi­tion­al years until June 27, 2029. If you are inter­est­ed, you may access the imple­ment­ing deci­sion here.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website