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White-label genetic testing guide

Saliva kits: medical device or not? What the intended purpose decides

Reviewed by Dr. Daniel Wallerstorfer, molecular biologist and founder of Novogenia · Updated: 13 October 2026 · Reading time: 11 min

In short

Whether a saliva collection kit is a medical device is not decided by the tube but by the manufacturer’s intended purpose. Under the IVDR (Regulation (EU) 2017/746), specimen receptacles are deemed in vitro diagnostic medical devices – but an in vitro diagnostic medical device is always a medical device with a medical purpose. Promotional and sales materials are part of the intended purpose (Art. 2(12)). Anyone who makes a medical device available under their own brand generally takes on the manufacturer’s obligations (Art. 16). Novogenia supplies kits as medical devices and as non-medical devices; we agree on the classification at the start. In Switzerland, the IvDV governs the product and the GUMG governs the test: for analyses on nutrition, sport and well-being, the sample must be collected in the presence of the prescribing health professional.

One tube, one sentence: what makes a kit a medical device

What turns a small sample tube into a medical device? Not the material, not the shape, not the price. It is a single sentence: the intended purpose. It states what the manufacturer intends the product for – and with it, which rules apply.

Think of the tube as an envelope and the intended purpose as the address. The envelope always looks the same. Only the address decides which route it takes and which rules apply along the way.

For your own genetic-test brand, this is no formality. The classification determines the framework in which you may offer and advertise your product, which obligations you take on, and whether your kit may be used in every country the way you plan. That is why Novogenia offers both versions: kits as non-medical devices and kits as medical devices. We work out together at the start which one fits your project.

This article shows you what the EU regulation on in vitro diagnostic medical devices says, what your logo on the kit changes, and why Switzerland asks two questions instead of one. It gives you orientation but does not replace legal advice for your specific case.

Three IVDR terms you should know

In the EU, Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) governs products used to examine specimens from the human body. For saliva collection kits, three definitions in Art. 2 matter most:

Term	What the IVDR says	What it means for your kit
In vitro diagnostic medical device (Art. 2(2))	a medical device intended by the manufacturer for the in vitro examination of specimens derived from the human body, to provide information – for example on a physiological or pathological state, the predisposition to a disease, or the predicted response to a treatment	Under Art. 2(1) of Regulation (EU) 2017/745, a medical device serves specific medical purposes. No medical purpose, no in vitro diagnostic medical device.
Specimen receptacle (Art. 2(3))	a device specifically intended by its manufacturer for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination; specimen receptacles are deemed in vitro diagnostic medical devices (Art. 2(2))	The tube in your kit can be an in vitro diagnostic medical device – even though it measures nothing itself.
Intended purpose (Art. 2(12))	the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use, in promotional or sales materials or statements, or in the performance evaluation	The label is not the only thing that counts. Your website and your advertising also describe what your kit is for.

One exception matters for research projects: products intended solely for research use are outside the IVDR – unless, in view of their characteristics, the manufacturer specifically intends them for in vitro diagnostic examination (Art. 1(3)(a)).

Lifestyle or medical: the intended purpose sets the course

These definitions lead to a clear logic. If an analysis is meant to provide information for a medical purpose – such as a predisposition to disease or how a medication works –, the kit falls within the IVDR. If it is about nutrition, sport, skin or lifestyle without a medical purpose, the picture looks different.

Question	Kit as a non-medical device	Kit as a medical device
What for?	lifestyle, wellness and research applications without a medical intended purpose	medical analyses
Who offers the analysis?	partners, within the rules of their country	where national law requires it, physicians only
What applies under the IVDR?	not an in vitro diagnostic medical device, as long as neither the label nor the advertising states a medical purpose	manufacturer’s obligations under Art. 10, EU declaration of conformity (Art. 17) and CE marking (Art. 18)
What applies to advertising?	no medical promises	no misleading claims about intended purpose, safety and performance (Art. 7)

Your advertising counts. Because promotional and sales materials are part of the intended purpose, a single sentence on your website can shake the classification. A kit for a nutrition analysis advertised with the promise “detects your disease risk” no longer fits a non-medical device. So write product copy, instructions and packaging as one piece – and check them against the classification. How to advertise genetic tests properly is covered in Advertising genetic tests: what is allowed.

National rules come on top. The IVDR does not affect national law requiring, for example, that only certain health professionals may dispense or use certain devices (Art. 1(9)). Which analyses belong in physicians’ hands in Germany and Austria is explained in Law: offering genetic tests in DE, AT and CH.

Your logo on the kit: who is actually the manufacturer?

A kit in your brand’s design is the heart of white label: your logo, your instructions, your packaging. For a kit as a non-medical device, this is mainly a matter of design and communication. On a medical device, your logo is more than design – it is a signature.

The IVDR defines the manufacturer as the person who manufactures a device, or has it manufactured, and markets it under their own name or trademark (Art. 2(23)). Art. 16(1) IVDR goes further. The manufacturer’s obligations also apply to anyone who

sells under their own name: makes a device available on the market under their own name, registered trade name or registered trademark (point (a)). Excepted are distributors or importers that agree with the manufacturer that the manufacturer is identified on the label and is responsible for the manufacturer’s obligations;
changes the purpose: changes the intended purpose of a device already on the market (point (b));
modifies the device: modifies it in a way that may affect compliance (point (c)).

Art. 10 shows what that means: manufacturers run a risk management system, carry out a performance evaluation, keep technical documentation up to date, draw up the EU declaration of conformity, affix the CE marking, and meet the obligations on the unique device identifier (UDI) and on registration.

For you, this means: before a medical-device kit with your logo ships, it must be settled in writing who the manufacturer is, who appears on the label and who carries which obligations. Clarify this right at the start – together with the classification.

Switzerland: two laws ask two different questions

In Switzerland, you have to answer two questions separately. The first concerns the product: may this kit be placed on the market? The second concerns the test: may this analysis be carried out this way? Each question has its own law.

The product: the IvDV. The Swiss Ordinance on In Vitro Diagnostic Medical Devices (IvDV, SR 812.219) largely adopts the IVDR’s terms: an in vitro diagnostic medical device is a medical device (Art. 3(1)), specimen receptacles are also deemed in vitro diagnostic medical devices (Art. 3(2)), and products intended solely for research are excluded (Art. 2(a)). For the manufacturer, it also refers to the clarifications in Art. 16 IVDR (Art. 4(1)(e)). Two points matter for the Swiss market: if the manufacturer is not domiciled in Switzerland, its devices may only be placed on the market if it has designated an authorized representative domiciled in Switzerland by written mandate (Art. 44(1)). And devices offered online to users in Switzerland are deemed to be made available on the market there (Art. 7(2)).

The test: the GUMG. The Federal Act on Human Genetic Testing (GUMG) governs who prescribes a genetic test and how the sample gets to the lab:

Tests for self-testing: Ready-to-use genetic tests that the manufacturer intends for use by the person concerned may only be supplied for other genetic tests (Art. 13 GUMG) – such as hair and eye color or the senses of smell and taste (Art. 37(3) of the ordinance (GUMV)).
Nutrition, sport, well-being: Only certain health professionals may prescribe these analyses (Art. 34 GUMG, Art. 40 GUMV), and the sample must be collected in the presence of the prescribing person (Art. 34(3) GUMG).
Medical tests: They are prescribed by physicians (Art. 20 GUMG). Under Art. 37(2) GUMV, these include analyses on topics such as food intolerances or an increased risk of sports injuries.

The IvDV explicitly connects the two worlds: when devices for self-testing are supplied, Art. 13 GUMG also applies (Art. 61(2) IvDV).

Question	IvDV (product)	GUMG (test)
What is it about?	whether the kit counts as an in vitro diagnostic medical device and which obligations the manufacturer meets	who prescribes the analysis, how the sample is collected and what the report may contain
What decides?	the manufacturer’s intended purpose	the category of the test: medical, particularly sensitive characteristics, or other
What does it mean for a home kit?	A kit can meet every product requirement …	… and still not be allowed for use alone at home for nutrition and sport analyses.

The difference from Germany: Germany’s Genetic Diagnostics Act (GenDG) applies under Section 2(1) to genetic examinations for medical purposes, for clarifying parentage, and in insurance and employment. The GUMG, by contrast, devotes a separate chapter to genetic tests outside the medical field. A lifestyle kit that can be mailed to consumers in Germany therefore needs a different route in Switzerland: through the prescribing health professional, in whose presence the sample is collected. How to handle this logistically is shown in Sample logistics: from kit to lab.

Checklist: the right kit for your project

You know the purpose of every analysis in your portfolio: lifestyle or medical?
The kit version matches the purpose: non-medical device for lifestyle analyses, medical device for medical analyses.
Website, packaging and instructions describe the same purpose – with no medical promises for lifestyle kits.
For a medical-device kit under your brand, it is settled in writing who the manufacturer is and who appears on the label (Art. 16 IVDR).
National rules are checked for every target country – in Switzerland, the IvDV and the GUMG.
In Switzerland, it is clear which health professional prescribes the analysis and in whose presence the sample is collected.
For research projects, it is documented that the kit is intended solely for research use.

Which analyses fit your portfolio is covered in Choosing the right test portfolio. More about the kits themselves: saliva collection kits.

How we do it at Novogenia

How we work with saliva collection kits at Novogenia:

Two versions: kits as non-medical devices for lifestyle, wellness and research applications without a medical intended purpose, and kits as medical devices for medical analyses.
Classification at the start: We work out together which classification is right for your use case before launch.
Your brand: kits assembled in your brand’s design – with your logo, your instructions and your packaging.
Ready to ship: instructions, packaging, return shipping materials and unique labeling are part of the kit. Collection works reliably without trained staff.
One source: On request, we link the kits directly to sample logistics and genetic analysis in our own lab in Eugendorf near Salzburg, Austria.
Quote: transparent, with volume tiers – from the first batch to ongoing supply.

Frequently asked questions

Is every saliva collection kit a medical device?

No. What matters is the manufacturer’s intended purpose. Under the IVDR, specimen receptacles are deemed in vitro diagnostic medical devices (Art. 2(2) and (3) of Regulation (EU) 2017/746). But an in vitro diagnostic medical device is always a medical device, that is, intended for a medical purpose. A kit for lifestyle analyses without a medical intended purpose is therefore classified differently from a kit for medical analyses.

Does my advertising count toward the intended purpose?

Yes. The IVDR defines the intended purpose by the information the manufacturer supplies on the label, in the instructions for use and in promotional or sales materials (Art. 2(12)). If you make medical claims for a lifestyle kit, the product and its classification no longer match. Art. 7 IVDR prohibits misleading claims about intended purpose, safety and performance.

Who is the manufacturer if my logo is on a medical-device kit?

Anyone who makes a device available on the market under their own name or trademark generally assumes the manufacturer’s obligations under Art. 16(1)(a) IVDR. The exception: a distributor or importer agrees with the manufacturer that the manufacturer is identified on the label and remains responsible for the manufacturer’s obligations. Settle these roles in writing before launch.

Can I mail kits to consumers in Switzerland?

Not as a pure home kit for analyses on nutrition, sport and well-being: these are prescribed by a health professional listed in Art. 40 GUMV, and the sample is collected in that person’s presence (Art. 34(3) GUMG). Tests for self-testing may only be supplied for other tests, such as hair color or sense of taste (Art. 13 GUMG). Medical tests are prescribed by physicians (Art. 20 GUMG).

Which kit fits a research project?

Products intended solely for research use are outside the IVDR unless, in view of their characteristics, the manufacturer specifically intends them for in vitro diagnostic examination (Art. 1(3)(a)). At Novogenia, the non-medical-device version is suitable for research applications without a medical intended purpose, among other uses.

Planning your own genetic-test brand?

Tell us about your audience and your preferred portfolio – we will show you how your launch could look.

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Note: This guide is general information for businesses and professionals and does not replace medical or legal advice. The genetic traits determined in a genetic analysis are well documented (each gene included is backed by at least three independent studies); recommendations derived from them are logical conclusions, not scientifically proven. Regulations can change; errors and changes excepted.