EUDAMED with its six mod­ules was planned as an impor­tant cor­ner­stone for the imple­men­ta­tion of Reg­u­la­tions (EU) 2017/745 and 2017/746 on med­ical devices (MDR) and in vit­ro diag­nos­tic med­ical devices (IVDR). EUDAMED was orig­i­nal­ly planned to be ful­ly oper­a­tional with the first date of appli­ca­tion of the MDR.

Sev­er­al delays were com­mu­ni­cat­ed in the past years – the last update pro­vid­ed for an expect­ed date of full oper­a­tion in 2024.

Now it seems the date by which the med­ical device data­base is due to be rec­og­nized as ful­ly func­tion­al, and the date by which report­ing into the data­base is due to be manda­to­ry, look like­ly to be post­poned yet again.

If the draft EUDAMED Roadmap pre­sent­ed at the recent Euro­pean Commission’s Med­ical Device Coor­di­na­tion Group meet­ing will be put into prac­tice, the date of full oper­a­tion will be post­poned until mid-2027! Accord­ing­ly, use of the EUDAMED mod­ules would not be manda­to­ry until 2029.

Rea­sons for the poten­tial delay are not enough resources and the lack of readi­ness of the clin­i­cal inves­ti­ga­tions module.

The legal sit­u­a­tion requires EUDAMED to have all six mod­ules ready until full func­tion­al­i­ty can be claimed. Experts call for a prac­ti­cal approach where full func­tion­al­i­ty can be con­firmed already at an ear­li­er stage. If this won’t hap­pen, this would mean that even though the mod­ules on actor reg­is­tra­tion, UDI/device reg­is­tra­tion, and on noti­fied body cer­tifi­cates are suf­fi­cient­ly ready to have already been launched on a vol­un­tary basis, they will not be offi­cial­ly launched. As a result, eco­nom­ic oper­a­tors will face fur­ther years of stag­gered time­lines to be con­sid­ered and a patch­work of local reg­is­tra­tion requirements.

Source: Medtech Insight (an Infor­ma product)

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