Team-NB pub­lished a new revi­sion of its best prac­tice guid­ance for Reg­u­la­tion (EU) 2017/745 (MDR), annex­es II and III. Ver­sion 3 stream­lines the sub­mis­sion of tech­ni­cal doc­u­men­ta­tion under the MDR aim­ing to reduce review delays and improve clarity.

Key high­lights are rec­om­men­da­tions for a well-struc­tured doc­u­men­ta­tion and guid­ance for ear­ly engage­ment with noti­fied bod­ies. For more details, check out the full doc­u­ment here. 

Team-NB also pub­lished a revi­sion (revi­sion 2) of its posi­tion paper on the EU AI Act (AIA). The paper offers a fresh per­spec­tive on nav­i­gat­ing the AIA! Team-NB’s updat­ed guid­ance clar­i­fies com­pli­ance for high-risk AI appli­ca­tions by empha­siz­ing trans­paren­cy, eth­i­cal gov­er­nance, and risk management.

Key focus areas are the align­ment with EU reg­u­la­to­ry frame­works and sup­port for inno­va­tion while safe­guard­ing fun­da­men­tal rights. The full paper can be accessed here.

Source: Team-NB

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website