In-house devices have a spe­cial sta­tus: they do not need to com­ply to the pro­vi­sions of Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices or in vit­ro diag­nos­tic med­ical devices (MDR and IVDR) respec­tive­ly. Instead these devices are only required to com­ply with the gen­er­al safe­ty and per­for­mance require­ments under annex I of the cor­re­spond­ing Regulation.

How­ev­er, there are nonethe­less cer­tain con­di­tions that must be met in this con­text. To pro­vide addi­tion­al clar­i­fi­ca­tion, the Med­ical Device Coor­di­na­tion Group (MDCG) issued MDCG 2023-1, Guid­ance on the health insti­tu­tion exemp­tion under Arti­cle 5(5) of Reg­u­la­tion (EU) 2017/745 and Reg­u­la­tion (EU) 2017/746.

Should you be inter­est­ed in receiv­ing a copy or fur­ther infor­ma­tion, please don’t hes­i­tate to get in touch. 

Source: MDCG

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