Team-NB’s Posi­tion Paper (adopt­ed Octo­ber 22, 2025) clar­i­fies how noti­fied bod­ies should deter­mine which changes to com­pan­ion diag­nos­tics (CDx) “affect per­for­mance, intend­ed use or suit­abil­i­ty”. It explains the manufacturer’s duty to assess and doc­u­ment whether a change is reportable, and the noti­fied body’s role in decid­ing if a sup­ple­ment or a full new con­for­mi­ty assess­ment is need­ed — includ­ing whether med­i­c­i­nal prod­uct author­i­ty con­sul­ta­tion is required. 

The paper is an inter­est­ing read also for reg­u­la­to­ry affairs pro­fes­sion­als work­ing at IVD man­u­fac­tur­ers as it explains the log­ic behind noti­fied body deci­sions and cross ref­er­ences man­u­fac­tur­er oblig­a­tions in the change process.

The doc­u­ment can be down­loaded here.

Source: Team-NB 

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Clin­i­cal evi­dence require­ments under the IVDR — MedTech Europe eBook
• New Q&A Guid­ance: MDCG 2025-5 on IVDR Per­for­mance Studies
• The Euro­pean Union sim­pli­fies the man­age­ment of multi­na­tion­al com­bi­na­tion prod­uct trials