The EU has pub­lished a series of tem­plates to help spon­sors of IVD per­for­mance stud­ies cor­re­spond with mem­ber states author­i­ties. For exam­ple, guid­ance doc­u­ment MDCG 2020-19 enti­tled Per­for­mance study application/notification doc­u­ments under Reg­u­la­tion (EU) 2017/746, includes an annex list­ing six tem­plates to sup­port spon­sors. These deal with:

  1. Per­for­mance study-appli­ca­tion/no­ti­fi­ca­tion form under Reg­u­la­tion (EU)2017/746 on in vit­ro diag­nos­tic med­ical devices
  2. Addi­tion­al per­for­mance device(s)
  3. Addi­tion­al com­para­tor device(s)
  4. Addi­tion­al site(s)
  5. Per­for­mance study sup­port­ing doc­u­ments-Appen­dix of doc­u­ments to attach
  6. Check­list of gen­er­al safe­ty and per­for­mance require­ments, stan­dards, com­mon spec­i­fi­ca­tions and sci­en­tif­ic opinions

Should you be inter­est­ed in hav­ing a copy of the new doc­u­ments, please don’t hes­i­tate to get in touch.

Source: Medtech Insight (an Infor­ma prod­uct), MDCG

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

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