The IVDR companion diagnostic consultation path: notified body, EMA and timing

Who decides what?

The notified body evaluates conformity with IVDR and remains the body that issues the device certificate. The medicines authority evaluates whether the companion diagnostic is suitable in relation to the medicinal product concerned. Where the medicinal product is centrally authorised, the consultation is with EMA; other cases may involve a national competent authority under the applicable route.

This division of responsibility is why a CDx project cannot be planned as a conventional IVD file with one additional form. The device review and medicinal-product scientific opinion are linked but distinct procedures.

What needs to align in the consultation package?

The package must tell one coherent clinical story. The biomarker definition, target population, medicinal-product context, specimen, cut-off, clinical role and performance evidence should not drift between the device intended purpose, study reports, medicinal-product dossier and labelling.

• Device description and intended purpose, including the associated medicinal product or product class.
• Scientific-validity, analytical-performance and clinical-performance evidence.
• Clinical-study information connecting test result, treatment decision and relevant outcomes.
• Proposed instructions for use and any testing or sample-handling constraints.
• A controlled response process for questions involving both device and medicinal-product teams.

Where timing risk enters the programme

Timing depends on more than the scientific-opinion clock. The notified body must first reach the appropriate review stage, the consultation package must be administratively and scientifically ready, questions must be answered across organisations and material changes can affect both pathways.

A workable plan identifies the consultation authority, notified-body expectations, dossier freeze points and cross-team decision rights before the final evidence package is assembled. The device and medicinal-product timelines should share one dependency map.

A practical starting point

Begin with a short classification and pathway memo: why the device is or is not a companion diagnostic, which medicinal product is implicated, which authority is expected to provide the opinion and which evidence or labelling elements are not yet aligned. That memo becomes the basis for discussions with the notified body and the medicinal-product team.

Assign responsibility for each device and medicinal-product document, including who consolidates responses to the notified body and medicines authority.

Agree the device–medicine interface before compiling the package

A companion diagnostic programme needs a shared description of the test, the medicinal product and the clinical decision supported. Bring the device and medicine teams together to reconcile the relevant population, specimen, result interpretation and claimed relationship. A mismatch in this interface can surface late even when each team has prepared its own documents carefully.

Maintain a cross-reference between the device claim, the supporting medicine-related evidence and the proposed information supplied with the device. If a study used a different assay version or decision threshold, identify that difference and the evidence needed to explain its relevance. Do not assume that a shared brand name makes two assay configurations equivalent.

Prepare a response process for questions across organisations

Separate scientific questions, documentary inconsistencies and requests for additional information. Each question should have an accountable owner, the source material needed for a response and a review path across the relevant organisations. A device team may need information held by a pharmaceutical partner; access and permitted use should be arranged before an urgent response is required.

Keep a record of which answers change the intended purpose, evidence interpretation or supplied information. Update all affected documents together. A response that fixes one paragraph but leaves a conflicting statement elsewhere creates avoidable uncertainty for the next review.

Distinguish procedural timing from the programme critical path

Use the current EMA procedural guidance and the notified body’s confirmed arrangements for the formal consultation pathway. In the wider programme plan, separately show evidence generation, package readiness, partner review and responses to questions. A procedural time period is not the same as the complete time needed to bring the device to market.

Before setting a launch assumption, record which dependencies are confirmed and which remain estimates. Changes to the medicine programme, assay or evidence availability should trigger an impact review. This keeps the consultation embedded in the development plan without presenting an authority’s scientific opinion as a blanket approval of every device claim.