You cannot place a device on the EU market without CE marking under MDR Article 5 — full stop. But you can generate revenue before CE marking through services, R&D contracts with hospitals, the custom-made device route under Annex XIII, and investigational device reimbursement under Article 62. Each path has strict boundaries. Crossing them is not a grey area; it is an illegal market placement.

By Tibor Zechmeister and Felix Lenhard.

TL;DR

  • MDR Article 5(1) prohibits placing a device on the market or putting it into service unless it bears CE marking and meets the MDR's requirements.
  • Four legal pre-CE revenue paths exist: paid services that do not require a regulated device, R&D collaboration contracts with hospitals or research institutions, custom-made devices under Annex XIII with the specific requirements met, and investigational devices under Article 62 where limited cost recovery may be allowed by the sponsor.
  • Selling "a device that happens to be uncertified" under any label — beta, pilot, research use only, pre-order — is not a legal path. It is placing a non-compliant device on the market.
  • Custom-made devices have a narrow, prescriptive definition in Article 2(3) and Annex XIII. They are not a workaround for avoiding CE marking on a serial-production device.
  • Revenue paths blur quickly when founders improvise. The safest rule: every euro of pre-CE revenue must map to a specific legal basis you can point to by article number.

Why this matters

Every MedTech founder hits the same wall. Development is taking longer than planned. The clinical data is not yet assembled. The notified body is booked out. CE marking is twelve to twenty-four months away. And investors — or the bank account — want to see revenue.

The temptation is obvious. A hospital wants to try the device. A clinician is willing to pay. A friendly reseller offers to distribute "for research use only." The founder reasons: if the customer understands the device is not yet certified, what harm is done?

The harm is that MDR Article 5 does not contain an exception for "the customer understood." Placing an uncertified device on the EU market is a regulatory offence with consequences ranging from withdrawal orders to fines to criminal liability in some member states. Worse, it poisons the subsequent CE marking process: a notified body that discovers past illegal placement will not certify the device without extensive remediation, and the past incidents will show up in the company's quality records forever.

There are legal pre-CE revenue paths. They are narrower than most founders think, and each has specific conditions. This post walks through all of them.

What MDR actually says

Article 5(1) — Placing on the market and putting into service. A device may be placed on the market or put into service only if it complies with the MDR when duly supplied, properly installed, maintained, and used in accordance with its intended purpose. "Placing on the market" is defined in Article 2(28) as the first making available of a device, other than an investigational device, on the Union market.

This is the hard wall. Every legal pre-CE revenue path must either (a) not constitute "placing on the market" or "putting into service," or (b) fall under a specific exception the MDR provides.

Article 21 — Devices for special purposes. The MDR distinguishes devices manufactured for special cases. Paragraph 1 states that custom-made devices do not require CE marking if they comply with Annex XIII. Paragraph 2 clarifies that investigational devices used in clinical investigations under Articles 62 to 82 are not subject to CE marking.

Annex XIII — Custom-made devices. A custom-made device is defined in Article 2(3) as any device specifically made in accordance with a written prescription of any person authorised by national law to give such a prescription and which is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. Annex XIII sets out the statement the manufacturer must draw up for each custom-made device, including identification of the patient, the healthcare professional issuing the prescription, the specific design characteristics, and a declaration that the device conforms to the GSPRs in Annex I. Custom-made devices are explicitly excluded from being serial-produced (Article 2(3) final sentence).

Article 62 — Clinical investigations: general requirements. Clinical investigations of devices not yet CE-marked are permitted under the conditions of Articles 62 to 82 and Annex XV. The sponsor must submit an application through the EU clinical investigation module, obtain approval from the competent authority and a favourable ethics committee opinion, and comply with EN ISO 14155:2020+A11:2024. Article 62(1) establishes that such investigations may be conducted to establish or verify safety and performance. The rules on compensation of subjects and investigators are set in national law; MDR Article 62(4)(k) addresses subject protection but leaves commercial reimbursement of investigational devices a matter of sponsor–site agreements within national frameworks.

Article 7 — Claims. This article prohibits misleading promotional content. While often cited in the context of CE-marked devices, Article 7 also constrains how you can describe an investigational or custom-made device in any pre-market communication.

A worked example

A Vienna-based startup is developing a Class IIb diagnostic software for ophthalmology. CE marking is eighteen months out. The founders have six months of runway. Three revenue paths are on the table:

Path A — Services contract with a university clinic. The clinic wants to use an early prototype in a feasibility project. The startup's engineers will operate the software themselves, process retinal images provided by the clinic, and deliver diagnostic reports signed by a clinician at the clinic. Revenue: EUR 80,000 over six months. Legal status: this is a service, not a device sale. The software is not placed on the market — the startup operates it as an internal tool and the clinic receives a report. This is legal, provided the engagement is structured as a service agreement and not as device delivery. The engineers' operation must not constitute putting the device into service for the clinic's own use.

Path B — Custom-made device for a specific patient. A surgeon wants a bespoke 3D-printed surgical guide for a single complex case. The startup can manufacture this under Annex XIII. Legal status: legal, if all Annex XIII requirements are met, including the written prescription, the individual patient identification, the conformity statement, and the restriction to a single patient's needs. This path does not scale — each device needs its own prescription and documentation — but it generates revenue and real clinical data. The startup cannot, however, use the custom-made route to ship ten "custom" devices that are actually the same product with different serial numbers. That is serial production disguised as custom work and is illegal.

Path C — Clinical investigation with cost recovery. The startup considers running a clinical investigation under Article 62 at three hospital sites and asking the hospitals to contribute to the cost of the investigational software. This is the thin ice. Article 62 permits the investigation. Whether the sponsor can recover costs from investigational sites depends on national rules and the specific nature of the contribution. Sponsors typically cover costs rather than charge them. Treating a clinical investigation as a revenue event is almost always a misreading of the framework. The safer framing: the investigation generates clinical data, which generates value, which can be monetised later through the CE-marked product.

Total legal revenue the founders can book from Paths A and B, realistically: EUR 150,000 to EUR 300,000 over the six months. Not enough to fund the company, but enough to extend runway while the real funding round closes.

The Subtract to Ship playbook

1. Default assumption: you cannot sell the device. Build every revenue plan from that baseline. Every legal pre-CE revenue path is an exception. Treating sales as the default and exceptions as escape hatches is how founders end up placing uncertified devices on the market. Invert the logic. Assume you cannot sell, then find the narrow, specific path that lets you earn revenue without placing the device.

2. Services revenue is the cleanest path. If your team operates the device and delivers an output (a diagnostic report, a surgical plan, a research dataset), you are providing a service — not placing a device on the market. Hospitals and clinical research organisations routinely pay for such services. Structure the contract as a service agreement. Make sure the device never leaves your operational control. Do not ship hardware that hospital staff will operate themselves, or software that hospital users will log into independently.

3. Custom-made is narrow, not a workaround. Custom-made devices under Annex XIII require a written prescription from a prescribing professional, individual patient identification, and the explicit restriction to that patient's needs. It is legal and useful for genuinely bespoke devices — bespoke implants, patient-specific surgical guides, prosthetics. It is not legal if the "custom" device is actually the same serial product with cosmetic variation. Notified bodies and competent authorities know the difference.

4. Research and development contracts are legitimate revenue. Hospitals, universities, and pharma companies pay for R&D collaborations. If your startup is contributing development work, data analysis, or regulatory expertise to a larger project — and the deliverable is a report, a protocol, or a data package, not a device — this is normal consulting or R&D revenue. It does not require CE marking because no device is being placed on the market.

5. Investigational device paths generate data, not revenue. Clinical investigations under Article 62 produce value — but that value is clinical evidence, not cash flow. Some sponsor–site agreements involve device provision at no cost; others include limited cost contributions from sites. Treat any cost recovery as a minor offset to investigation expenses, not as a revenue line. Competent authorities look closely at any investigation that appears to be commercial placement dressed as research.

6. Never, ever sell an uncertified device with a disclaimer. "For research use only," "not for clinical decisions," "pilot version," "beta access," "pre-order" — none of these labels create a legal exception to Article 5. The MDR applies to devices placed on the market, and placement is an objective fact, not a contractual description. If the customer can use the device for its intended purpose, it is placed on the market, regardless of the label on the box.

7. Track every pre-CE euro to a specific legal basis. In your books, every invoice raised before CE marking should map to one of: services revenue, R&D contract revenue, grant revenue, custom-made device revenue under Annex XIII, or investigational device cost recovery under Article 62. If an invoice does not fit one of these categories, it is likely illegal placement. Your auditor, your notified body, and eventually your acquirer's due diligence team will check this.

Reality Check

  • Can you point to the specific MDR article (5, 21, 62) or annex (XIII, XV) that authorises each pre-CE revenue stream in your plan?
  • Does any of your pre-CE revenue involve shipping a device to a customer who will operate it independently?
  • If you plan to use the custom-made route, is each device actually made for a specific, identified patient with a written prescription from an authorised prescriber?
  • Does your services model keep the device under your team's operational control at all times?
  • Have you confirmed with your accounting team that pre-CE revenue is categorised correctly (services, R&D, grants, custom-made, investigational) and not booked as device sales?
  • Have you read the national rules of the member state where each pre-CE transaction happens, not just the MDR text?
  • Would your notified body be comfortable seeing your pre-CE revenue history during the initial audit?
  • Is there any pressure from investors or the board that is pushing you toward a path you would not otherwise take?

Frequently Asked Questions

Can we sell an "early access" version of our device before CE marking? No. "Early access," "beta," "pilot," "preview," "pre-order" — none of these create an exception to Article 5. If the customer will use the device for its intended medical purpose, it is placed on the market and requires CE marking.

Can we give the device away for free before CE marking? Free distribution of a device for its intended medical purpose is still "making available on the market" and is prohibited. Free distribution is only legal within specific exceptions: investigational devices under Article 62, custom-made devices under Annex XIII, or internal use by the manufacturer (for example, demonstration at a trade show where the device is not actually used on patients).

What about selling to non-EU customers before CE marking? That depends on the importing country's rules, not on the MDR. The MDR only applies to devices placed on the EU market. A device shipped directly to a customer in a non-EU country is governed by that country's medical device regulation. However, some countries require proof of CE marking before they accept imports, so the absence of CE marking may close markets.

Is a "research use only" label a legal workaround? Not under MDR. The RUO concept exists in some contexts (for example, in the EU IVDR for certain research tools) but does not create a general exception under the MDR for medical devices. If the device is used for its intended medical purpose, it is a medical device and requires CE marking.

Can we charge hospitals for investigational devices used in our clinical investigation? Generally, sponsors cover the costs of investigational devices, not the other way around. Any cost contribution from sites must be transparent, justified, and compliant with national rules. Treating clinical investigations as a revenue stream is a red flag for competent authorities.

Does operating the device ourselves as a service really avoid placing it on the market? Yes, if it is a real service and not a disguised sale. The legal distinction is that the device remains under your control and you deliver an output (a report, a result) rather than the device itself. The moment hospital staff operate the device independently, you have put it into service and triggered MDR obligations.

Sources

  1. Regulation (EU) 2017/745 on medical devices, consolidated text. Articles 5, 7, 21, 62–82, Annexes XIII, XV.
  2. EN ISO 14155:2020+A11:2024 — Clinical investigation of medical devices for human subjects — Good clinical practice.