Back­ground

On 18 June 2025, the Med­ical Device Coor­di­na­tion Group (MDCG) released MDCG 20255, Ques­tions & Answers regard­ing per­for­mance stud­ies of in vit­ro diag­nos­tic med­ical devices under reg­u­la­tion (EU) 2017/746. MDCG 2025-5 is a Ques­tions & Answers doc­u­ment clar­i­fy­ing per­for­mance study require­ments under the EU’s In Vit­ro Diag­nos­tic Med­ical Devices Reg­u­la­tion (IVDR). This guid­ance is designed pri­mar­i­ly for spon­sors and man­u­fac­tur­ers involved in per­for­mance stud­ies of IVD med­ical devices (IVDs) rang­ing from ana­lyt­i­cal val­i­da­tion to clin­i­cal investigation.

Pur­pose

The doc­u­ment serves mul­ti­ple objectives:

  1. Clar­i­fy study scope
    It dis­tin­guish­es between ana­lyt­i­cal per­for­mance stud­ies (e.g., accu­ra­cy, pre­ci­sion) and clin­i­cal per­for­mance stud­ies (e.g., sen­si­tiv­i­ty, speci­fici­ty), out­lin­ing when each type is required or may be waived based on justification.
  2. Guide reg­u­la­to­ry path­ways
    It helps stake­hold­ers deter­mine whether a per­for­mance study must be applied for (e.g., for inva­sive pro­ce­dures under Arti­cles 58/70) or sim­ply noti­fied to com­pe­tent author­i­ties (e.g., stud­ies with left­over samples).
  3. Clar­i­fy roles and bur­den of proof
    It rein­forces that the man­u­fac­tur­er owns the device’s intend­ed pur­pose, which shapes the per­for­mance study design and reg­u­la­to­ry oblig­a­tions. It also high­lights the respon­si­bil­i­ty of spon­sors to con­sid­er nation­al eth­i­cal review along­side IVDR requirements.
  4. Clar­i­fy spe­cial cas­es
    It explains how to han­dle com­pan­ion diag­nos­tics, sub­stan­tial mod­i­fi­ca­tions dur­ing ongo­ing stud­ies, and cri­te­ria dis­tin­guish­ing per­for­mance stud­ies from oth­er research.

Why it matters

This guid­ance adds clar­i­ty to the com­plex field of per­for­mance stud­ies under the IVDR. It pro­vides advice to spon­sors, man­u­fac­tur­ers, and noti­fied bod­ies and thus helps to ensure designs are com­pli­ant, risks are man­aged, and the evi­dence col­lect­ed sup­ports safe­ty and per­for­mance claims. 

The doc­u­ment can be down­loaded from our web­site.

Source: Euro­pean Commission 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website