New MDCG Guidance on performance studies of IVDs

In June 2025, the Medical Device Coordination Group (MDCG) published a new guidance document on performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 (IVDR). MDCG 2025-5 presents over 50 Q&A relevant for manufacturers providing IVDs for use in performance studies in the EU sponsored by other actors, and sponsors of combined studies.

General considerations on performance studies in the EU

The IVDR defines a performance study as a study undertaken to establish or confirm the analytical or clinical performance of an IVD medical device. This definition cover also studies involving artificial samples. Article 57 of the IVDR regulates all performance studies and Articles 58 and 70 can apply when subjects might be exposed to addition risks:

Nonetheless, certain studies might be subject to particular requirements, depending on the study nature. Among others, this includes studies involving companion diagnostics, invasive procedures, and clinical interventions.

Application and notification of a performance study

Not all performance studies need to be submitted to the competent authority. According to the IVDR, performance studies in scope of Article 58(1), Article 58(2) or Article 70 need to be submitted (application or notification) to the competent authority. Importantly, it is not necessary to submit an application in Member States where only analysis sites are located but no specimens are collected from study subjects.

Until the EUDAMED module for performance studies is functional, the CIV-ID (sometimes referred to as PS-ID for performance studies – generated by a competent authority) serves as Union-wide single identification number.

Specifically, MDCG 2022-19 provides guidelines on the documentation necessary for such applications and notifications.

Sponsors of clinical investigations: legal representative

Are you a sponsor of a clinical investigation under the MDR and based outside of the EU? We can act at your legal representative. Having a legal representative based in the EU is a mandatory requirement for non-EU sponsors.

For any comments or questions on performance and clinical studies, ask here or at mdlaw@obelis.net.