Selling diagnostics as Research Use Only in Europe: a go-to-market strategy that works, if you respect its boundaries

For international diagnostics companies waiting for CE-IVDR certification, the European market can feel binary: either you have the CE mark and you can sell, or you do not and you cannot. A third option exists. It is already being used by companies that understand both its potential and its limits.

Research Use Only (RUO) products are excluded from the scope of the In Vitro Diagnostic Regulation (IVDR, Regulation EU 2017/746). According to Article 1(3)(a), products intended for research use only are not subject to the regulation, provided they are not intended by their manufacturer for diagnostic examination. The MDCG 2024-11 guidance confirms that RUO products cannot have a medical intended purpose.

This creates a legitimate commercial space. RUO is not a regulatory category defined in the IVDR; it is a market convention that derives from the intended purpose exclusion. Whether a product qualifies as outside the IVDR's scope depends entirely on the manufacturer's intended purpose (Article 2(12)), not on the label alone. But the space is narrow, with hard boundaries on every side. Understanding where those boundaries are is the difference between a viable market preparation strategy and a compliance problem.

What the strategy can do

An RUO go-to-market strategy is not a commercial launch. It is a market preparation phase with three objectives.

Product awareness. Research laboratories that use your RUO product become familiar with its performance and workflow before the CE-marked version exists. When the CE mark arrives, you are not introducing an unknown product. You are formalising access to something the scientific community has already tested.

Scientific positioning. Investigators who use your product in their research may publish results, present at conferences, and develop expertise with your technology. These relationships are difficult to build after a commercial launch. They develop more naturally during a research phase, when no commercial pressure exists.

Institutional familiarity. In markets like Italy, where over 50 IRCCS research hospitals combine clinical care with mandated scientific research, the institutions that use your RUO products today may be the same institutions that procure your CE-marked product tomorrow. The IRCCS network covers the disease areas (oncology, genomics, rare diseases) where the molecular diagnostics market is growing fastest, with a strong concentration in Northern Italy.

The boundaries that matter

RUO and CE-IVDR certification are separate tracks

This is the most commonly misunderstood point.

A manufacturer cannot sponsor a formal clinical performance study using a product labelled RUO. Under the IVDR, if a study is designed to generate performance data for a CE-IVDR submission, the product must be classified and labelled for performance evaluation, following the regulation's specific requirements (Articles 57-77, Annexes XIII and XIV). When the intent is regulatory submission, RUO and performance evaluation are legally distinct categories and cannot be interchanged. Early exploratory or feasibility research may use RUO products, but the moment the work is structured to support conformity assessment, the IVDR's performance study regime applies.

However, there is an important nuance. The IVDR permits manufacturers to reference published, peer-reviewed scientific literature in their Performance Evaluation Report (Annex XIII). If an independent institution buys your RUO product, conducts its own research, and publishes the results, those findings can legitimately contribute to your evidence base. Independence is not a strict regulatory requirement under Annex XIII, but it strengthens credibility: a Notified Body will give more weight to published evidence that was not designed or sponsored by the manufacturer seeking certification.

The practical implication: the RUO commercial track and the regulatory track must remain strictly separated. But the scientific literature that independent RUO users generate can, over time, build the broader evidence landscape that supports your regulatory file. In practice, however, manufacturers must be able to demonstrate that the product used in published studies is representative of the version submitted for CE marking, or provide appropriate bridging data where changes have occurred.

No disguised clinical use

An RUO product must not be placed on the market or promoted for clinical diagnostic decision-making. The IVDR regulates the manufacturer's intended purpose, not medical practice directly, but the boundary is enforced through the manufacturer's commercial behaviour. The core principle in IVDR enforcement is that regulators assess intended purpose based on objective evidence: not only the label, but also claims, instructions for use, marketing materials, and actual use context. A company that sells RUO products systematically to hospital departments with no active research programme, or that provides clinical interpretation guidance alongside the product, may be creating evidence of diagnostic intent regardless of the label.

The in-house device exception

There is one scenario in which an RUO product does enter a clinical workflow, and it is entirely legal. Article 5(5) of the IVDR (clarified by MDCG 2023-1) permits healthcare institutions to develop in-house diagnostic devices (Laboratory Developed Tests) without CE marking, provided no equivalent CE-marked IVD meeting the appropriate level of performance is available on the market. This requirement is subject to transitional provisions extended by Regulation (EU) 2024/1860, which delays full application of certain Article 5(5) conditions; the specific requirements in force at any given time should be verified.

In this case, the hospital purchases RUO reagents and assumes full responsibility for converting them into a clinical test under its own governance. The manufacturer sells a legitimate RUO product; the institution takes on the clinical responsibility.

The boundary for the manufacturer: you cannot promote or imply clinical intended use for your RUO product, and your involvement must not amount to co-development of a clinical test. Providing general technical support and training on product use is acceptable; marketing for clinical application is not. In practice, the institution must be able to demonstrate that the clinical use decision was its own and was not driven by the manufacturer. But this pathway represents a real and distinct market segment that diagnostics companies should understand.

Procurement and funding constraints

When selling RUO products to public research hospitals such as Italian IRCCS, procurement follows the Codice dei Contratti Pubblici (Legislative Decree 36/2023). In practice, institutions typically use research-dedicated budgets(independent grants, Ministry of Health research funding, European grants) for RUO purchases. While there is no explicit law mandating this, a mismatch between funding source and product use may trigger scrutiny during audits: if clinical funds are used for products labelled "research only," the question of intended purpose inevitably follows.

The exception is the in-house device pathway: when a hospital buys RUO components to build its own Laboratory Developed Test under Article 5(5), clinical funds are appropriate because the institution's intended purpose is clinical. But this is the hospital's initiative, not the manufacturer's.

Privacy, ethics, and intellectual property

Any research involving human biological samples in Europe is subject to the GDPR. In Italy, the Garante per la Protezione dei Dati Personali has taken notably restrictive positions on the secondary use of biological samples for commercial purposes.

When a commercial company wants to access samples or data from an Italian research hospital for its own industrial R&D, the process typically involves formal ethics committee review covering not only the privacy framework but also the intellectual property arrangements. Material Transfer Agreements (MTAs) and Data Transfer Agreements (DTAs) generally define who owns the results, how publications are managed, and what conditions apply. Public institutions often require agreements that reflect the value of the institutional contribution, though the specific terms vary by institution and by the nature of the collaboration.

What the strategy is not

The RUO approach is sometimes described as a way to "enter the market early" or "generate revenue while waiting for CE-IVDR." Both descriptions need qualification.

You are entering the research market, not the clinical diagnostics market. The research market is smaller, governed by specific funding rules, and generates a fraction of the revenue that clinical sales produce. The financial return from RUO sales should be understood as a secondary benefit, not the rationale for the strategy.

You are not accelerating the CE-IVDR process. The regulatory pathway runs on its own track, with its own requirements. The RUO track and the regulatory track are parallel but separate. Neither substitutes for the other.

The real value is strategic: product familiarity, scientific publications, investigator relationships, and institutional knowledge of the European clinical landscape. These assets compound over time and translate into faster adoption when the CE mark is obtained. Companies that treat the RUO phase as structured market preparation will enter the post-CE market with advantages that competitors who waited cannot replicate.

Frequently asked questions