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

Executive answer

Under IVDR Article 48(3), a notified body assessing a companion diagnostic must seek a scientific opinion from a competent medicines authority or the EMA before issuing an IVDR certificate. EMA is involved when the associated medicinal product falls within its remit, including centrally authorised medicines. The notified body submits the consultation package, remains responsible for the device conformity assessment and must give due consideration to the scientific opinion.

Key points

• Confirm companion-diagnostic status and the medicinal-product route early.
• The notified body initiates the formal consultation; the manufacturer prepares the evidence package through that process.
• Device and medicinal-product teams need aligned intended use, biomarker, population and clinical-study narratives.
• Consultation dependencies belong in the programme critical path, not in a late certification checklist.

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.

FirsTeckBio supports the device-side evidence chain—from intended-purpose review and performance evaluation through study planning and technical-documentation coordination—while the formal authority interaction remains within the roles defined by IVDR and the applicable EMA procedure.

Primary sources and review

• EMA: Companion diagnostics (in-vitro diagnostics)
• EMA: Guidance on the notified-body consultation procedure for companion diagnostics
• EUR-Lex: Regulation (EU) 2017/746, Article 48