--- title: "The Harmonisation Gap: Managing EU Performance Study Submissions" description: "Discover why IVDR performance study submissions remain fragmented across Europe and how regulatory differences impact timelines and study strategy." url: https://qbdgroup.com/en/blog/ivdr-performance-study-submissions-europe type: "Blog post" language: en published: 2026-05-06 author: "Kirsten Van Garsse" publisher: "QbD Group" citation: "QbD Group, \"The Harmonisation Gap: Managing EU Performance Study Submissions\", https://qbdgroup.com/en/blog/ivdr-performance-study-submissions-europe" --- # The Harmonisation Gap: Managing EU Performance Study Submissions > Discover why IVDR performance study submissions remain fragmented across Europe and how regulatory differences impact timelines and study strategy. If you have experience submitting clinical trials under the European Union (EU) Clinical Trials Regulation (CTR), you may expect a similar process for your in vitro diagnostic (IVD) performance study. You would be wrong. The regulatory landscape for performance study submissions under the **In Vitro Diagnostic Regulation (IVDR)** remains fragmented, inconsistent, and often time-consuming. If you do not plan for it, it can easily cost you months. In this blog, we explore why IVDR performance study submissions remain operationally complex, how differences between Member States impact timelines, and why regulatory intelligence remains essential for combined drug-diagnostic studies. ## Two Regulatory Worlds, One Combined Study In a combined drug-diagnostic study, the pharmaceutical side benefits from a centralized submission through the **Clinical Trial Information System (CTIS)**. One application covers all participating Member States, supported by a coordinated review process and defined timelines. The system is designed for efficiency, even if not always perfect in practice. The IVD side does not yet benefit from a comparable centralised submission system. In the absence of a fully functional **European Database on Medical Devices (EUDAMED)**, performance study applications must still be submitted individually to each participating Member State, including countries where samples are collected. Each country has: - Its own expectations - Its own format requirements - Its own operational process Some countries use dedicated e-portals. Others accept submissions by email. Some still require printed binders shipped physically by post. This divergence creates substantial administrative complexity that can catch sponsors off guard. It is also important to understand that the diagnostic submission remains **entirely separate** from the clinical trial application for the drug. You cannot assume that completing the pharma submission covers the device. Even within authorities themselves, different departments handle the two frameworks. They are fundamentally separate systems. ## Sample Origin Triggers Obligations One important and frequently misunderstood point is that IVDR applicability is driven by: - The origin of the patients - The intended use of the assay It is not determined solely by where testing takes place. If samples are collected from EU patients, the IVDR will generally apply, even if analysis takes place outside the EU. This also applies to companion diagnostic studies using leftover samples. Under **Medical Device Coordination Group (MDCG) 2025-5** guidance, notification under Article 58(2) is required in all Member States participating in the performance study where the study falls within IVDR scope. This may include: - Countries where samples are collected - Countries where analysis takes place - Countries where relevant performance study activities occur The practical implication is clear: sponsors must assess obligations across the **full operational footprint** of the study, not only where laboratory testing occurs. ## Timelines That Vary Widely While the IVDR defines indicative review timelines for competent authorities, there are no harmonised timelines for ethics committee reviews. Depending on the country and the submission strategy used, approval timelines may range from **three to nine months**. This is a planning reality that must be incorporated from the outset. Different Member States apply different procedural approaches: ### Consolidated Approach A single application reaches both the ethics committee and competent authority simultaneously. Belgium is a well-known example of this approach. ### Sequential Approach The ethics committee review must first be completed, including all requests for information (RFIs), before submission to the competent authority can begin. ### Parallel Approach Both submissions proceed simultaneously but independently, with separate reviews, RFIs, and approval timelines. The complexity increases further when different Member States issue different RFIs, potentially leading to diverging versions of: - The Clinical Performance Study Plan (CPSP) - The Investigator's Brochure (IB) - The Informed Consent Form (ICF) Once approvals are obtained, sponsors may ultimately need substantial modifications simply to realign all participating countries on harmonised study documentation. ## Strategic Submission Approaches Smart sequencing can significantly improve timelines. Countries with consolidated review systems often provide faster pathways to first patient in. Starting with these *"easier"* countries and onboarding more complex Member States later can help maintain overall programme timelines. Similarly, some sponsors first initiate studies in the United States (US), where approval timelines for performance studies are often shorter, while EU submissions continue in parallel. Another critical consideration is the coordination between: - The pharmaceutical clinical trial application - The IVD performance study submission Several competent authorities increasingly expect the **pharmaceutical dossier to be submitted before** accepting the IVD application. Submitting the performance study too early may result in: - Requests to withdraw - Application holds - Delayed review timelines This is not theoretical. We have seen this happen in practice. ## Plan for the Patchwork The current lack of harmonisation is unlikely to disappear overnight. Initiatives such as the **COMBINE programme** are actively exploring whether performance study applications can eventually be integrated into CTIS workflows. Meanwhile, EUDAMED is expected to streamline submissions and support more coordinated assessments in the future. For now, however, **regulatory intelligence remains a critical success factor**. Sponsors must understand: - Which portals each Member State uses - Which formats are expected - How national review processes function - How submission strategies impact timelines This is where experienced regulatory support can make a measurable difference to programme execution and approval timelines. ## Looking to Go Deeper? Combined drug-diagnostic studies continue to expose operational and regulatory grey zones across Europe. **[Watch the webinar: Grey Zones & Growing Pains in Drug-Diagnostic Co-Development](/en/webinars/navigating-grey-zones-growing-pains-regulatory-cdx-space)** ## Ready to Strengthen Your IVDR Submission Strategy? At QbD Group, we support sponsors in navigating IVDR performance study requirements, coordinating multi-country submissions, and aligning regulatory strategy across complex combined studies. **[Planning a multi-country IVD performance study in Europe? Talk to our experts and anticipate the operational realities early.](/en/contact)** --- Source: https://qbdgroup.com/en/blog/ivdr-performance-study-submissions-europe — © QbD Group. Quote freely with attribution and a link back.