Diagnostics as a Service for telemedicine: what a remote consultation may do in Germany and which company is the maker of the test kit
When a telemedicine clinician needs a blood value, most platforms send the person somewhere else and find out later whether they went. German rules allow more than most teams assume. Here is what a remote consultation may do, whether it can order a test, and who owns the kit you ship.
Written by
Robert Jakobson
Published on
September 28, 2026
Remote consultations work until a clinician needs a blood value. Then your service has a problem. Diagnostics as a Service is one answer to that problem, and a referral is the other. With a referral the person is told to go somewhere else for the draw. Your platform then finds out later whether they went.
Before a platform chooses between those two answers, it has to know what the German rules let a remote service do at all. This article sets that out, starting with what a purely remote consultation may do. It then covers how much of a practice's work may be done by video, and whether a clinician may order a blood test for somebody seen only on screen. It ends with the kit, because a kit that goes out under your own brand raises a question about who counts as its maker.
What can a remote consultation do in Germany?
The rules for doctors allow it, within limits. The model professional code allows treatment purely through communication media in the individual case.1 Three conditions apply. The treatment has to be medically justifiable, the required standard of care has to be kept, and the person has to be told what is different about a remote consultation.1
That code is a model rather than the law itself. Each state medical chamber adopts its own version, so the binding text for your clinicians is the one their own chamber has adopted.
Advertising a remote service is allowed within a narrower limit. The advertising law bans promoting remote treatment unless generally recognised professional standards say a face to face contact is not needed for that condition. The Bundesgerichtshof applied exactly that limit when it ruled against an advertisement that offered remote treatment across conditions in general.2
A purely remote service in Germany may consult, diagnose and treat in the individual case, prescribe, refer and certify short sick leave. It may not advertise remote treatment in general terms. Sources: section 7 paragraph 4 of the model professional code, section 9 of the Heilmittelwerbegesetz, and the Bundesgerichtshof judgment of 9 December 2021.
How much video consulting is allowed?
Up to half of a practice's work. Since 1 April 2025 a practice may treat up to half of its treatment cases each quarter purely by video. The limit counts only cases handled entirely by video. It applies per practice location, and it leaves out emergencies and people who are also seen in person.3
How much is allowed is one question. How much is actually done is a separate question, which the published count answers. The Zentralinstitut für die kassenärztliche Versorgung counted 3.2 million statutory video consultations in 2025, which was 17.9 percent more than in 2024.4
Can a clinician order a blood test for somebody seen only on video?
The published guidance says it can be permissible. The Bundesärztekammer states that a referral during purely remote treatment can be permissible where the professional rule is observed alongside the ordinary referral rules of the collective agreement.5
Whether that holds in a given consultation is a judgement for the treating clinician and their state chamber. A supplier does not make that judgement.
Two caveats belong with that guidance. The first is that it speaks about referrals in general rather than about laboratory orders by name. The second concerns privately insured people, because the terms of their own policy may restrict what is covered.5
What this means for a Diagnostics as a Service order
The professional rule gives one more reason to read a test order as permitted. It names the taking of findings among the care that has to be kept in a remote consultation.1 A blood test is one way of taking findings.
Read together with the guidance above, ordering a test is one way a remote consultation keeps that standard of care rather than a way around the rule. Neither document says that in those words, so treat it as our reading. The state chamber is the body that settles it.
Does shipping a test kit make us a device manufacturer?
It can, depending on the label. Under the European rules for diagnostic devices, a distributor takes on the manufacturer's duties when it makes a device available under its own name or trade mark.6
A kit that goes out under your brand alone therefore makes you the maker in law. The same article allows one way out. Where an agreement names the original maker on the label and keeps that maker responsible for the maker's requirements, the distributor stays a distributor.6 Whether a particular agreement does that is a question for your own regulatory adviser.
If the kit carries the original maker's name and an agreement leaves the duties with them, the platform is a distributor. Under the platform's own brand, the platform takes on the maker's duties. Sources: Regulation (EU) 2017/746, Articles 16(1)(a) and 48(10), and MDCG 2020-16 revision 5 of September 2026.
How the device rules apply to a Diagnostics as a Service kit
Two further points decide how heavy the maker's duties are for this kind of kit.
Guidance from the Medical Device Coordination Group treats a kit meant only for a lay person to collect a sample as a collection device rather than a self-test, and it normally places such a kit in the lowest risk class.7
At that class the maker declares conformity itself, without a notified body, unless the kit is supplied sterile.8
So the kit question is a branding decision with a regulatory consequence. Decide it before the first kit is printed rather than discovering it afterwards.
What stays with the platform whatever it buys
The clinical responsibility stays with you. A supplier does not take on the clinical decision, the prescription, or the duty to meet the professional standard in the individual case. Those belong to whoever runs the consultation.
What should a telemedicine platform ask a supplier?
The questions follow the stages of a build, so they are set out in that order.
While you are still choosing a supplier: what does your collection coverage look like in the regions we already serve?
Before the first kit is printed: who is named as the manufacturer on the kit we ship, and what does the agreement say?
While your own interface is being built: how do we receive a result, and with which codes and units on it?
Before the first abnormal result: what happens then, and who is responsible for that conversation?
The last question is the one a real case will test. Its answer belongs in the contract rather than in the onboarding call.
Where Aniva is on this
The consultation ends where your clinician decides a blood value is needed. Aniva begins at that point, when your clinician orders inside your own product. The collection, the accredited laboratory work and the result then run as one service that delivers the result back into your product. The network that collects the sample is Aniva's own rather than a subcontractor's.
At no point does a user meet the Aniva brand. Whose name goes on the kit is a separate choice that belongs with your own regulatory advice and with the agreement you sign.
Book a demo if you want to see the ordering, the kit and the result as your interface would receive it.
Section 9 of the Heilmittelwerbegesetz, whose second sentence was added by the Digitale-Versorgung-Gesetz and took effect on 19 December 2019, and the judgment of the Bundesgerichtshof of 9 December 2021 in case I ZR 146/20. www.gesetze-im-internet.de/heilmwerbg/__9.html
Regulation (EU) 2017/746 on in vitro diagnostic medical devices, Article 16(1)(a), under which a distributor assumes the manufacturer's obligations when it makes a device available under its own name or trade mark, subject to the agreement exception. eur-lex.europa.eu/eli/reg/2017/746/oj/eng
Regulation (EU) 2017/746, Article 48(10), under which makers of the lowest risk class declare conformity themselves after drawing up the technical documentation, with a different route where the device is supplied sterile. eur-lex.europa.eu/eli/reg/2017/746/oj/eng
This article describes German professional rules and European device rules as they affect a telemedicine service buying blood testing. It is general information and not legal advice, and your own arrangement is a question for your own adviser.
Add blood testing to your business
Aniva provides the labs, the test kits, the shipping, the software and the data protection paperwork. You offer blood tests under your own brand. Tell us which tests you need and we will show you how it works.
