The Med­ical Device Coor­di­na­tion Group (MDCG) recent­ly pub­lished MDCG 2024-2, Pro­ce­dures for the updates of the Euro­pean Med­ical Device Nomen­cla­ture. The doc­u­ment lays out details regard­ing stake­hold­ers and time­lines for reg­u­lar updates of EMDN codes. As a reminder, EMDN codes rep­re­sent the nomen­cla­ture of med­ical devices under the med­ical devices and in vit­ro diag­nos­tic med­ical devices reg­u­la­tions (MDR and IVDR). 

The pro­ce­dure enables users of the nomen­cla­ture sys­tem to request, for exam­ple, the assign­ment of new codes. These will then be eval­u­at­ed and poten­tial­ly pub­lished at the end of a cal­en­dar year if the request was sub­mit­ted by Jan­u­ary 31 of the same cal­en­dar year the lat­est. MDCG 2024-2 also pro­vides for an expe­dit­ed ad hoc review for new codes. Addi­tion­al details, e.g. a link to the plat­form for EMDN requests are con­tained in the guid­ance document. 

Fur­ther­more, MDCG 2024-3 was pub­lished, Guid­ance on con­tent of the Clin­i­cal Inves­ti­ga­tion Plan for clin­i­cal inves­ti­ga­tions of med­ical devices. The guid­ance gen­er­al­ly ref­er­ences annex XV of the MDR and stan­dard ISO 14155:2020. It pro­vides advice on spe­cif­ic aspects that are required in clin­i­cal inves­ti­ga­tion plans, such as ben­e­fits and risks of the inves­ti­ga­tion­al device and the clin­i­cal inves­ti­ga­tion, objec­tives and hypothe­ses, the inves­ti­ga­tion design, sta­tis­ti­cal design and analy­sis and adverse event han­dling. 

Man­u­fac­tur­ers and eco­nom­ic oper­a­tors are high­ly rec­om­mend­ed to con­sid­er the doc­u­ments if applicable.

Source: MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website