The Euro­pean Com­mis­sion has recent­ly updat­ed the com­mon spec­i­fi­ca­tions (CS) for cer­tain high-risk in vit­ro diag­nos­tic med­ical devices (IVDs) under Reg­u­la­tion (EU) 2017/746 (IVDR). The revised pro­posed text out­lines new detailed CS for detect­ing Hepati­tis E virus, Tox­o­plas­ma gondii, Plas­mod­i­um spp., and four types of arboviruses. 

The dead­line for feed­back on these amend­ments was Sep­tem­ber 16. This update comes two years after adopt­ing the orig­i­nal CS and aims to enhance the reg­u­la­to­ry frame­work for these prod­ucts in the Euro­pean Union.

Accord­ing to amend­ing reg­u­la­tion (EU) 2024/1860, lega­cy class D IVDs must com­ply with the new IVDR rules by Decem­ber 31, 2027. The Com­mis­sion has intro­duced CS to focus on the tech­ni­cal per­for­mance char­ac­ter­is­tics of IVDs due to insuf­fi­cient cov­er­age by har­monised stan­dards. This is to address pub­lic health con­cerns relat­ed to sig­nif­i­cant risks asso­ci­at­ed with the use of these devices. In addi­tion to the 13 IVD cat­e­gories cov­ered by the orig­i­nal amend­ing reg­u­la­tion adopt­ed in 2022, sev­en new CS are now included.

Source: Medtech Insight (an Infor­ma product)

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