The European Medicines Agency's Combination Products Operational Group (COMBO) has agreed to draft a proposal for the Medical Device Coordination Group (MDCG) outlining the information needed in the Summary of Safety and Performance (SSP) for companion diagnostics, with an expected delivery around Q4 2026. The group also discussed clarifying the definition of suitability for companion diagnostics consultation procedures and addressing regulatory challenges for assays that support clinical decision-making but do not fully meet the companion diagnostic definition.
In a highlight report published on 2 July 2026, covering a virtual meeting held on 12 June 2026, the COMBO in vitro diagnostics stream, chaired by Alberto Ganan Jimenez (EMA), addressed several topics. The group focused on the scope and process of suitability assessment in the Medicines Competent Authorities consultation for companion diagnostics, emphasising the roles of the Medicines Product Authority, notified bodies, and the need for alignment on information requirements. The overall aim of the consultation on suitability should be to confirm, based on information available to the MPA (draft SSP/IFU), that the medicinal product is effective in the patient group identified by the companion diagnostic candidate. The group agreed to incorporate the clarified definition of suitability into EMA guidance documents and update the SSP template or its instructions to better address companion diagnostic requirements.
Participants also considered the timeline for the companion diagnostic consultation procedure as defined under the In Vitro Diagnostic Regulation (IVDR), including whether there may be flexibility in how the rules are applied. This topic will be further developed to clarify the degree of flexibility. Additionally, the group explored regulatory and practical challenges of assays that do not fully meet the definition of companion diagnostics but are used in clinical decision-making, focusing on intended use, oversight, and the distinction between IVDs and CDx. Members presented cases where biomarkers are mentioned in the Summary of Product Characteristics (SmPC) but are not part of the formal indication, raising questions about how such assays can be legally marketed and whether they require certification as IVDs or CDx. The group clarified that most IVDs support clinical decision-making without being strictly defined as CDx, and their intended use is determined by the manufacturer and verified by notified bodies. CDx are strictly defined under IVDR, while other assays with a medical purpose are regulated as IVDs. The link between intended purpose and clinical evidence is addressed in ongoing projects, emphasising that clinical evidence for one medicinal product cannot automatically be used for another, and performance studies may still be required depending on the intended use.
The COMBO group's work impacts several stakeholders. For pharmaceutical companies developing targeted therapies, clearer guidance on companion diagnostic suitability and SSP content could streamline regulatory submissions and reduce uncertainty. Diagnostic manufacturers face potential changes in certification requirements for assays that are not strictly companion diagnostics but are used in clinical decision-making, which may affect their market access strategies. Notified bodies will need to align with the clarified definitions and information requirements, potentially adjusting their assessment processes. Patients may benefit from more precise diagnostic tools linked to effective treatments, but could face delays if regulatory clarification leads to additional performance studies or certification steps.