Diagnostics as a Service across Europe, and what changes at every border

Diagnostics as a Service is usually bought by companies that already sell blood testing in one European country and assume the second country will be easier than the first, because the hard part of building the product is behind them. That assumption is reasonable, but it turns out to be wrong, because the parts of a testing operation that matter were never European to begin with.

The European Union has more or less admitted this in writing. Under the European Health Data Space regulation, laboratory results are the last category of health data to come under EU-wide interoperability and access rules. Those rules only apply to laboratory results from 26 March 2031, which is two full years after the date set for patient summaries and prescriptions.¹

The same regulation explains why that date is so distant. It cites the treaty provision leaving the organisation and delivery of health services to each member state,² and the rules deciding who may test whom were written inside those national systems.

So Europe is one single market for your software while it remains twenty-seven separate systems for your diagnostics. The rest of this article covers what that difference costs a growing brand, and which parts of it a partner can take on for you.

Four separate things change at the same time

You can put software into a new market in an afternoon, because all you do is add a language and a currency, check the local consumer law and then open the doors.

Blood testing is a physical service performed by a licensed person inside a system that each country built for itself. That means you take on four separate pieces of work at the same time, but none of them was written into your plan.

• You need a new laboratory relationship on new terms, with no negotiating history behind you.
• You need a new collection arrangement, because the rules on who may draw blood are written nationally.
• You need a new set of contracts and a new data agreement for that market.
• You need a fresh answer to whether a customer in that country needs a doctor involved at all.

Any one of those pieces of work is manageable on its own, but taking on all four of them again in every country you enter is why most companies stop expanding after their second market.

The supporting infrastructure is spread unevenly as well. Nineteen bodies across Europe are currently designated to assess in vitro diagnostics, those nineteen are based in only twelve countries, and nine member states have none at all.³ That matters a great deal if you intend to sell your own test kit, because the assessment capacity is not where most people would guess.

Who may order a test is decided nationally

This is the rule that brands most often assume works the same way everywhere.

Some countries allow a person to buy a blood test for themselves with nobody else involved at any point. Others require a doctor to request the analysis before a laboratory may run it, even where the customer is paying privately. A few countries fall between those two positions, so the customer chooses the test while a medically qualified person still has to be a formal part of the process.

That one difference changes your product and not simply your paperwork. In one country the customer simply pays and books an appointment, while in the next country a medically qualified person has to be part of the process. That means finding a clinician, contracting them and building an extra step into your interface.

Germany shows why this needs checking rather than assuming. A person can pay privately for testing there, but the law governing laboratory analysis still conditions disease-related testing on a request from a physician or an equivalent professional.⁴ Both of those statements are true at the same time, and a plan built on the first one alone will produce an unpleasant surprise later.

Who may take the sample is a second national decision

Once you have settled who orders the test, you still have to settle who is legally allowed to perform it, and European countries disagree about the answer.

• In some markets a nurse may take blood on their own judgement, with no prescription needed.
• In others a nurse may only do so on a doctor's order, which puts a doctor back into your process.
• In at least one market, laboratory technicians have been ruled out of taking blood on their own initiative, so every draw costs nursing time.
• Sweden is unusually open about this. Its regulator states that within voluntary healthcare there are no specific rules on who may take a blood sample, and that the care provider assigns the task to staff with suitable competence.⁵
• Belgium is the most permissive market we have examined so far. Venous and capillary blood collection appears there as a nursing act that requires no medical prescription at all.⁶

The consequence of all this is economic rather than legal. A market where a trained non-physician may take the sample costs one amount to serve, and a market that needs a doctor present costs a different amount. Both of those markets can work commercially, though they will never work on the same model, which is why a single European price for a blood draw does not exist.

In one country the constraint is your wording

The Netherlands deserves a section of its own, because the rule there stops brands that have done everything else correctly.

Dutch law requires a ministerial permit to run population screening for certain serious conditions.⁷ If you describe your offer as screening for serious disease then you may need a permit you do not hold, whereas the same test described as a health check that a person chooses for themselves puts you in different territory.

The test itself is identical in both cases, and only the wording has changed.

That example is the general lesson of this article in miniature. Expansion problems in diagnostics are rarely about capability, because they are almost always about a specific national rule that nobody on your team knew to look for.

Several of these national rules are being relaxed

Having said all of that, several European countries are relaxing these rules rather than tightening them, so any structure you build rigidly around today's position will be wrong within a few years.

France widened the places where the analytical phase of laboratory work may happen outside a laboratory in early 2026, subject to authorisation and a named responsible medical biologist.⁸ That change matters to anyone planning to collect samples away from clinical premises.

Germany now permits pharmacists to take venous blood after they complete physician-led training. The model curriculum for that training is still being written, so the channel is legally open without being usable yet, and we have covered that reform in detail on our pharmacy site.

More collection points and fewer gatekeepers is the pattern almost everywhere in Europe, so the sensible thing is to build for that rather than around today's restrictions.

One part of diagnostics is the same in every country

Everything described above changes at a border, but one part of the work is the same in every country, and that is the part worth designing your product around.

A sample taken by a trained person and analysed by an accredited laboratory produces a result you can use, wherever the collection happened. The analysis is the constant part of your product, while collection and permissions have to be arranged again in each new country.

There is one important qualification, and it is the detail most teams discover far too late. Reference intervals have never been harmonised between laboratories. A 2023 review in Clinical Chemistry puts it plainly, saying that significant and unwarranted variation in reference intervals continues to exist across laboratories, including between laboratories using the same analytical method. The published consequence is a raised risk of misinterpreting a result.⁹

For a brand selling a single test that is a footnote in the documentation. For a brand selling repeat testing it is the entire product, because a customer whose value moves when the laboratory changed rather than when their health changed has been told something untrue. We go through how to handle that during a migration in our article on changing the laboratory behind your product.

Five questions worth asking a Diagnostics as a Service partner

Given everything above, these are the questions that separate a supplier from a partner.

• Do you handle the local permissions in each market, or does that fall to me?
• Who is legally responsible for the collection in each country you serve?
• Do results arrive in one format regardless of country, so that I build once?
• How are reference intervals handled when a sample is analysed somewhere new, and what happens to a customer's existing history?
• How long does adding a country take, and what do you need from me to do it?

The last question matters most of all. A supplier will give you a laboratory, whereas a partner gives you a repeatable way into a market, so that your fourth country costs less effort than your second.

How Aniva delivers Diagnostics as a Service across Europe

Aniva builds this as a repeatable pattern instead of a separate arrangement in every country.

• You get one contract, one integration and one result format, so that you build against Europe a single time.
• Aniva owns its blood draw network across Germany, which is the European market with the most demanding rules.
• We curate reference intervals alongside the laboratory-reported ones, so a customer's history stays readable when the analysis moves.
• Where a market needs a local permission, a local professional or a local laboratory, that work belongs to us and not to you.
• Diagnostics as a Service, or DaaS, is available to partners across Europe, and we are in active conversations with brands in many European countries.
• Adding a country follows a process we have already run rather than one we invent for you.

What we will not do is hand you a map claiming every country is live. Coverage depends on the panel, the collection method and the market in question, so we answer it specifically on a first call rather than generally in an article.

Tell us which countries you are entering and which panel you want to sell there. You can book a 30-minute demo, or read the API documentation first if your engineers want the shape of it. If you are still weighing this against running the whole operation yourself, we have set out what that involves separately.

A summary of the main points

• Laboratory results do not come under EU-wide interoperability rules until 2031, because health services remain a national competence.
• Who may order a test and who may take the sample are two separate national decisions, and both of them change your product.
• In the Netherlands the binding constraint is how you describe the offer rather than what you are permitted to do.
• Several markets are loosening their rules, so avoid building a rigid structure around today's position.
• The analysis is the same wherever the sample is taken, while collection, permissions and reference intervals have to be arranged in each country.
• Ask a prospective partner how long adding a country takes and what they need from you, because that answer tells you what you have found.

Questions we are asked most often

Can one partner cover blood testing across several European countries?

Yes, provided the partner handles the local layer in each market. What has to be arranged country by country is who may order a test, who may take the sample and which laboratory analyses it. What can stay constant is your contract, your integration and the format your results arrive in. Ask specifically who takes responsibility for the local permissions.

Do customers need a doctor to order a blood test in Europe?

That depends entirely on the country. Some allow a person to buy a test with nobody else involved, while others require a request from a physician or an equivalent professional before a laboratory may run a disease-related analysis, even where the customer pays privately. Germany is an example where private payment is possible and the analysis still requires a professional request.⁴

Who is allowed to take a blood sample in Europe?

This is set nationally and it varies more than people expect. Sweden's regulator states that there are no specific rules within voluntary healthcare on who may take a sample.⁵ Belgium lists blood collection as a nursing act needing no prescription at all.⁶ Other markets require a doctor's order, and at least one restricts the role further. The difference affects your cost per draw rather than whether the draw is possible.

Why does the wording of my offer matter so much?

Because at least one European country regulates population screening for serious conditions separately and requires a ministerial permit before you may do it.⁷ The same test described as a health check that a person chooses for themselves is in a different legal position from the same test described as screening for serious disease. Have your wording reviewed locally before you launch anywhere.

What happens to my customers' historical results if the laboratory changes?

Reference intervals are not harmonised between laboratories, including between laboratories using the same analytical method, and the published consequence is a raised risk of misinterpreting a result.⁹ If you sell repeat testing then comparability across a customer's history is part of your product, so ask any partner how they handle it.

How long does it take to add another country?

That depends on the panel, the collection method and the market you are entering. The more useful question is what the partner does themselves and what they need from you, because that determines whether your fourth country is easier than your second.

Notes and sources

1. Regulation (EU) 2025/327 establishing the European Health Data Space. Article 14(1)(e) defines medical test results, including laboratory and other diagnostic results and related reports. Article 105 applies that category from 26 March 2031, against 26 March 2029 for patient summaries, prescriptions and dispensations. EUR-Lex
2. Regulation (EU) 2025/327, recital 28, citing Article 168 of the Treaty on the Functioning of the European Union: member states are responsible for their health policy, in particular the organisation and delivery of health services and medical care. The regulation establishes national competence over the organisation of health services. That the rules on ordering a test or taking blood follow from it is our inference and not a statement in the text. EUR-Lex
3. European Commission list of designated notified bodies, checked 21 August 2026. Nineteen are designated under Regulation (EU) 2017/746 for in vitro diagnostics, against fifty-two under Regulation (EU) 2017/745 for medical devices. Two of the nineteen carry an ambiguous status flag, so a conservative count is seventeen. Single Market Compliance Space
4. § 5 of the Gesetz über die Berufe in der medizinischen Technologie (MTBG), Germany. lxgesetze.de. The official text is published at gesetze-im-internet.de and should be checked there before any verbatim quotation.
5. Socialstyrelsen, Sweden, on who may take a blood sample. socialstyrelsen.se
6. Belgian royal decree of 18 June 1990, coordinated 8 April 2016, listing technical nursing acts. Venous and capillary blood collection appears as a B1 act requiring no medical prescription. infirmieres.be
7. Wet op het bevolkingsonderzoek, Netherlands. Article 2 covers screening involving ionising radiation, cancer, and serious diseases for which no treatment or prevention is possible. Article 3 prohibits such screening without a ministerial permit. wetten.overheid.nl
8. Arrêté of 4 February 2026, France, published in JORF of 7 February 2026, widening the places where the analytical phase may be performed outside a laboratory, subject to authorisation by the regional health agency, a convention with the laboratory and a named responsible medical biologist. Légifrance
9. Bohn MK, Bailey D, Balion C, Cembrowski G, Collier C, De Guire V, Higgins V, Jung B, Mohammed Ali Z, Seccombe D, Taher J, Tsui AKY, Venner A, Adeli K. Reference interval harmonization: harnessing the power of big data analytics to derive common reference intervals across populations and testing platforms. Clinical Chemistry 2023;69(9):991 to 1008. doi:10.1093/clinchem/hvad099
10. Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Annex VIII, classification rules. legislation.gov.uk

This article is general information about how blood testing is regulated differently across European countries. It is not legal advice, and national rules change. Confirm your own position in each market with a local advisor. Laboratory accreditation and reference intervals belong to the analysing laboratory, and interpretation of any individual result remains with a treating clinician.