EU noti­fied body tech­ni­cal doc­u­men­ta­tion reviews

The noti­fied body asso­ci­a­tion, TEAM-NB, has issued a posi­tion paper, Best Prac­tice Guid­ance for the Sub­mis­sion of Tech­ni­cal Doc­u­men­ta­tion under Annex II and III Med­ical Device Reg­u­la­tion (EU) 2017/745. The paper intends to lay out what is need­ed in a tech­ni­cal doc­u­men­ta­tion sub­mis­sion and advis­es a frame­work for using evi­dence from assess­ments under the med­ical devices directives. 

The approach that is described in the posi­tion paper has been part­ly made pos­si­ble by the MDCG 2022-14 posi­tion paper in which the Med­ical Device Coor­di­na­tion Group (MDCG) rec­om­mend­ed a 19-point plan to, among oth­ers, boost noti­fied body capac­i­ty. One rec­om­men­da­tion for noti­fied bod­ies was to devel­op a frame­work for using evi­dence from ear­li­er assess­ments under the directives.

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• mdi Europa expe­ri­ence on MDR tech­ni­cal doc­u­men­ta­tion reviews
• Clin­i­cal eval­u­a­tion and equiv­a­lence – using lit­er­a­ture under the MDR
• Guid­ance doc­u­ment for class I device manufacturers
• New Euro­pean Com­mis­sion guid­ance doc­u­ment on MDR med­ical device classification