MedTech Europe’s Clin­i­cal Evi­dence Require­ments under EU In Vit­ro Diag­nos­tics Reg­u­la­tion (IVDR) con­sol­i­dates expert Q&As to help man­u­fac­tur­ers nav­i­gate the IVDR’s height­ened per­for­mance-eval­u­a­tion expec­ta­tions. First pub­lished in 2020 and now updat­ed through a fourth edi­tion, the doc­u­ment reflects col­lec­tive indus­try and author­i­ty expe­ri­ence dur­ing the tran­si­tion to the new IVD framework. 

Pur­pose

Its pur­pose is prac­ti­cal: to trans­late IVDR require­ments into action­able guid­ance on ana­lyt­i­cal and clin­i­cal per­for­mance stud­ies, evi­dence gen­er­a­tion strate­gies, equiv­a­lence jus­ti­fi­ca­tion, study design, use of lega­cy data, com­pan­ion diag­nos­tics, and doc­u­men­ta­tion for CE cer­ti­fi­ca­tion. The guid­ance aims to reduce inter­pre­ta­tion vari­abil­i­ty between man­u­fac­tur­ers, noti­fied bod­ies and author­i­ties and to sup­port con­sis­tent, com­pli­ant submissions. 

Key points

Key take­aways for reg­u­la­to­ry teams include focused advice on struc­tur­ing per­for­mance eval­u­a­tion reports, pri­ori­tis­ing clin­i­cal ques­tions, align­ing study end­points with intend­ed pur­pose, and doc­u­ment­ing benefit–risk. This remains an essen­tial, non-bind­ing ref­er­ence for IVD reg­u­la­to­ry strat­e­gy and CE-mark preparedness.

The doc­u­ment is a good help for man­u­fac­tur­ers to com­ply with the belong­ing reg­u­la­to­ry require­ments. It can be accessed here.

Source: Medtech Europe

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