MDCG 2020-16 rev.5 — new clar­i­ty on IVD con­trols under rule 7

The Med­ical Device Coor­di­na­tion Group (MDCG) has pub­lished revi­sion 5 of its guid­ance on the IVDR clas­si­fi­ca­tion rules (Reg­u­la­tion (EU) 2017/746, Annex VIII). It sup­ports man­u­fac­tur­ers, noti­fied bod­ies and health insti­tu­tions in assign­ing the cor­rect risk class (A–D) before an IVD is placed on the market.

Per the revi­sion table, rev.5 is lim­it­ed to rule 7. Rule 7 con­cerns con­trols with­out a quan­ti­ta­tive or qual­i­ta­tive assigned val­ue. These fall under risk class B. The ratio­nale was clar­i­fied and the exam­ples revised.

Key points to consider:

• Stand­alone qual­i­ty con­trol (QC) mate­ri­als are need­ed to mon­i­tor the valid­i­ty of lab­o­ra­to­ry exam­i­na­tion pro­ce­dures; the IFU should clear­ly spec­i­fy this intend­ed pur­pose and that stand­alone QC mate­ri­als do not replace the QC required to ver­i­fy IVD performance.
• Indica­tive val­ue ranges stat­ed by the man­u­fac­tur­er in the IFU (pres­ence or con­cen­tra­tion range of the ana­lyte) are not “assigned val­ues”; such stand­alone QC mate­ri­als remain class B.
• Diag­nos­tic-relat­ed con­trols with assigned quan­ti­ta­tive or qual­i­ta­tive val­ues fol­low imple­ment­ing rule 1.6.

The guid­ance doc­u­ment can be down­loaded here.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• AI Act: Com­mis­sion con­sults on trans­paren­cy and high-risk clas­si­fi­ca­tion guidelines
• MDCG 2021-24 Rev.1, updat­ed clas­si­fi­ca­tion guid­ance published
• Man­u­al on Bor­der­line and Clas­si­fi­ca­tion under the MDR and IVDR updated