For oncology diagnostics, Italy is the logical first market in Europe
CE-IVDR changed the rules. Italy's IRCCS network, aging demographics, and clinical research culture make it the strategic first step into Europe for cancer diagnostic companies.
When diagnostics companies outside Europe begin planning their entry into the EU market, they rarely choose Italy first. The instinct is to start where the infrastructure is familiar — Ireland for its English-language environment, Germany for the size of its hospital market, the Netherlands for its regulatory proximity to Notified Bodies. Italy, in this mental hierarchy, comes later: a large market, certainly, but a complicated one. Something to tackle once the European operation is established.
This sequencing is understandable. It is also, for a specific and growing category of diagnostics companies, strategically wrong.
For companies developing oncology diagnostics — liquid biopsy panels, next-generation sequencing assays, companion diagnostics, early detection tests for age-correlated cancers — Italy offers a combination of clinical, regulatory, and commercial advantages that no other European market replicates.
The argument is not sentimental. It is built on three structural realities that are reshaping the economics of European market entry under the new CE-IVDR framework.
Three structural realities
The regulation changed the calculus
Clinical evidence generation is the true bottleneck in the CE-IVDR pathway — not the technical file, not the QMS, not even the Notified Body queue.
For Class C oncology diagnostics, CE-IVDR requires designing and executing studies in real clinical settings, with real patient populations, that produce data meeting Notified Body standards. The company that can do this efficiently gains a structural time advantage measurable in months, sometimes years.
51 hospitals most foreign companies have never heard of
Italy's IRCCS institutions are simultaneously treating centres and research hubs — carrying the patient volumes of major public hospitals with the research infrastructure of academic medical centres.
These institutions have established frameworks for industry collaboration, ethics committee processes familiar with device validation studies, and biobank infrastructure that supports sample collection at CE-IVDR scale. A well-prepared company can initiate a clinical validation study in a timeframe not achievable at comparable institutions in Germany or France.
The demographic argument, stated precisely
Italy's median age — among the highest globally — is not merely a future commercial opportunity. For diagnostics targeting age-correlated oncological conditions, it is a present regulatory resource.
CE-IVDR requires clinical evidence generated in populations representative of the intended use. For age-correlated cancers, Italy's patient population is concentrated, accessible, and managed in research-grade settings — a materially different proposition from countries where patients are dispersed or institutional infrastructure less developed.
CE-IVDR: from self-declaration to clinical proof
The transition to CE-IVDR introduced a requirement that most non-European companies initially underestimate: the obligation to generate clinical evidence that is scientifically valid, representative of the intended patient population, and sufficient to support the claimed performance of the device.
This is not a documentation exercise. For a Class C oncology diagnostic — which covers the majority of cancer-related IVDs, including most molecular panels and liquid biopsy assays — the clinical evidence requirement means designing and executing studies in real clinical settings, with real patient populations, that produce data meeting the standards of a Notified Body review.
Companies that have navigated FDA clearance processes are accustomed to analytical validation and limited clinical bridging studies. CE-IVDR asks for something more systematic, more prospective in its design, and more demanding in its statistical rigour.
The IRCCS advantage
Italy operates a network of 51 IRCCS — Istituti di Ricovero e Cura a Carattere Scientifico, or scientific research hospitals — that occupy a unique position in the European clinical landscape. They are simultaneously treating institutions and research centres, funded partly by the national health service and partly by the Ministry of Health on the basis of their scientific output.
Patient access
Patient populations in Italian IRCCS oncology units are large, well-characterised, and accessible. Italy has one of the oldest populations in the world — meaning the disease burden in age-correlated cancers is concentrated in institutions that have been studying it systematically for decades.
Structured for partnership
The IRCCS system has established frameworks for industry collaboration, ethics committee processes familiar with device validation studies, and biobank infrastructure that supports sample collection at CE-IVDR scale.
The clinical evidence that emerges from this process does more than satisfy a regulatory requirement. It creates the foundation for clinical adoption in the Italian market before the CE certificate is even issued — a commercial dividend that market entry through a regulatory-only lens entirely misses.
The core strategic logic
Designing a clinical validation study for a lung cancer liquid biopsy panel in a country where the relevant patient population is concentrated, accessible, and already being managed in research-grade clinical settings is a materially different proposition from designing the same study in a market where the patients are dispersed, the institutional infrastructure is less developed, or the research culture around industry partnership is less mature.
This sequencing — clinical validation generating both regulatory evidence and market adoption simultaneously — converts a cost centre (clinical evidence generation) into a market development investment, because the same study that satisfies the Notified Body also creates clinical champions, generates real-world performance data for reimbursement negotiations, and establishes credibility with Italian oncologists before the first commercial conversation.
What Italy is not
An honest argument requires stating what Italy does not offer, or does not offer easily.
Challenges to navigate with local expertise
Reimbursement complexity: A CE mark does not translate automatically into market access. The SSN reimburses through a combination of national procedures and regional formulary decisions, introducing heterogeneity that surprises companies accustomed to centralised health systems.
Procurement cycles: Institutional decision-making involves relationship-building processes that Anglo-American commercial cultures find frustrating.
Linguistic barriers: Less significant in research and regulatory contexts than in purely commercial ones, but real.
These are not arguments against Italy. They are arguments for entering Italy with local expertise rather than without it. A company that understands how the SSN reimbursement system works at both the national and regional level, that has relationships with IRCCS clinical partners, and that knows which regions to target first for proof-of-concept reimbursement will navigate these challenges efficiently. A company that discovers them after launch will not.
The right question to ask
The standard question
"Where is the largest market, and how do we access it?"
That leads to Germany.
The more useful question
"Where can we generate clinical evidence efficiently, in a representative population, while simultaneously building clinical relationships that drive adoption?"
That leads to Italy.
Italy is not a compromise, and not a secondary consideration. It is the logical first step in a European strategy built around the regulatory reality rather than against it.
Leonardo Biondi helps international diagnostics companies identify and build the clinical partnerships in Italy that serve both CE-IVDR validation requirements and long-term market access strategy. If you are designing your European entry and want a frank assessment of whether an Italy-first approach fits your product and timeline, book a 30-minute call.