The Med­ical Device Coor­di­na­tion Group (MDCG) issued two addi­tion­al guid­ance doc­u­ments in Decem­ber 2019.

The “Explana­to­ry notes on MDR codes” pro­vide fur­ther clar­i­fi­ca­tion on the use of des­ig­na­tion codes of Noti­fied Bod­ies (NB) under Reg­u­la­tion (EU) 2017/745. The codes describe for which scope an NB is des­ig­nat­ed, but also what qual­i­fi­ca­tions the NB staff must have for assess­ing a device. 

For man­u­fac­tur­ers, it is impor­tant to have a good under­stand­ing of the log­ic behind because they must select an NB who is able to sup­port the cor­re­spond­ing prod­uct scope. Also, NBs may require man­u­fac­tur­ers to pro­vide the scope of their prod­ucts when they lodge their application.

Man­u­fac­tur­ers may devel­op a bet­ter under­stand­ing of how NBs will review

The “Guid­ance on sam­pling of MDR Class IIa / Class IIb and IVDR Class B / Class C devices for the assess­ment of the tech­ni­cal doc­u­men­ta­tion” pro­vides valu­able def­i­n­i­tions for a gener­ic device group and cat­e­go­ry of devices. The guid­ance fur­ther­more states that NBs must “assess the tech­ni­cal doc­u­men­ta­tion of at least one rep­re­sen­ta­tive device per gener­ic device group (for Class IIb and Class C) and for each cat­e­go­ry of devices (for Class IIa and Class B) pri­or to issu­ing the cer­tifi­cate.” By read­ing the doc­u­ment, man­u­fac­tur­ers may devel­op a bet­ter under­stand­ing of how NBs will review the tech­ni­cal doc­u­men­ta­tion and how the doc­u­men­ta­tion should be organized.

Sources: MDCG guid­ance documents

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