NB Consultation with EMA: Three Procedures, Three Timelines, One Unified Map

The Notified Body auditor sets down his pen and looks across the table.

"Before we can issue this certificate," he says, "we need to consult EMA."
The room goes quiet. Not because anyone is surprised — they knew this was coming. But because nobody at the table can say with certainty which procedure applies, how long it will take, or what documentation EMA actually expects.

Three different consultation procedures exist under MDR and IVDR — each with its own legal basis, timeline, documentation requirements, and fee structure. And the EMA Q&A documents that explain them are spread across six different sections, multiple revisions, and separate procedural guidance documents that reference each other in circles.

This is the unified map. One reference, three procedures, everything your team needs to know before the NB picks up the phone.

The Three Consultation Types You Need to Know

Why this matters: Each consultation type has fundamentally different requirements, timelines, and consequences. Applying the wrong procedure doesn't just waste time — it can invalidate the conformity assessment entirely.

The first two consultation types involve the CHMP (Committee for Medicinal Products for Human Use) or CAT (Committee for Advanced Therapies). The third — the Clinical Evaluation Consultation Procedure — involves Expert Panels rather than EMA committees, and applies to specific high-risk devices regardless of whether they incorporate medicinal substances.

What makes this confusing for teams is that the same Notified Body might need to initiate different consultation types for different devices in its portfolio, and the procedural requirements for each are documented in entirely separate guidance documents.

Who Consults Whom — And Why It Matters

Why this matters: The roles in this process are counter-intuitive. The manufacturer does most of the work and pays all the fees — but the Notified Body is the one who formally talks to EMA.

Across all three consultation types, the Notified Body is the formal applicant. This isn't just a procedural formality — it means the NB controls the submission timeline, manages the regulatory interaction with EMA, and makes the final certification decision based on EMA's opinion.

The phrase "due consideration" is deliberately ambiguous. For ancillary blood derivatives, an unfavorable EMA opinion is binding — the NB cannot issue the certificate. For other consultation types, the NB theoretically retains discretion, but deviating from an unfavorable EMA opinion would require extraordinary justification and would likely face challenge during market surveillance.

Ancillary Substance Consultation: The 210-Day Path

Why this matters: This is the longest and most complex of the three consultation procedures — and the one most likely to create project timeline surprises.

When a device incorporates a substance that would be a medicinal product if used separately, and that substance has an action ancillary to the device's function, the quality, safety, and usefulness of that substance must be assessed through consultation. The legal basis is MDR Article 1(8) and Annex IX, Section 5.2.

The 210-day timeline follows the same assessment timetable as a new centralised procedure application, including clock stops for the applicant to respond to questions. Accelerated assessment may be possible when the device addresses a serious disease or uses a known substance from a known source — but justification must be submitted 2-3 months before the planned application.

For a detailed walkthrough of the ancillary substance dossier requirements, variation types, and realistic timelines, see our dedicated guide: Ancillary Substance Consultation: The 210-Day Process That Gates Your CE Mark.

Companion Diagnostic Consultation: The 60-Day Path

Why this matters: The CDx consultation is faster than the ancillary substance path, but its unique complexity lies in the dual dependency between the diagnostic device and the corresponding drug.

Companion diagnostics are defined in IVDR Article 2(7) as devices "essential for the safe and effective use of a corresponding medicinal product." The consultation requirement under Article 48 exists to verify that the diagnostic is genuinely suitable for the therapeutic decision it enables.

EMA consultation is mandatory when the corresponding medicinal product is centrally authorised or falls exclusively within the centralised procedure's scope. For nationally authorised drugs, the NB and manufacturer can choose between EMA and a national authority.

The consultation is based entirely on two documents — the draft Summary of Safety and Performance (SSP) and the draft Instructions for Use (IFU). Unlike the ancillary substance consultation, which evaluates quality and safety comprehensively, the CDx consultation focuses specifically on suitability.

For the complete procedural breakdown including documentation strategies and follow-up consultation triggers, see: CDx Consultation Under IVDR: The 60-Day Procedure That Determines Your Market Access.

Clinical Evaluation Consultation: The Expert Panel Path

Why this matters: This consultation type applies even when your device has no medicinal substance component — it's triggered by device risk class and clinical evaluation questions.

The Clinical Evaluation Consultation Procedure (CECP) under MDR Article 54 is fundamentally different from the other two consultation types. It doesn't involve CHMP or CAT — instead, it routes through Expert Panels established under Article 106 of the MDR.

The CECP follows a 60-day timeline and results in a scientific opinion on the Notified Body's clinical evaluation assessment. The Expert Panel may recommend additional clinical investigations or identify gaps in the clinical evidence that the NB must address before certification.

Fee Structure: What Each Consultation Actually Costs

Why this matters: These fees are charged to the manufacturer, not the NB, and they're substantial enough to require budget planning at the project level.

Two practical details that are easy to miss: if a device incorporates multiple ancillary substances or blood derivatives, only the highest applicable fee is charged — not a fee for each substance. And manufacturers with registered SME status at EMA's SME office qualify for fee reductions across all consultation types.