What the IVDR governs
The In-Vitro Diagnostic Regulation 2017/746 (IVDR) replaces the older IVD Directive (IVDD) and, since 2022, governs across Europe how in-vitro diagnostics are developed, manufactured, classified, approved and monitored. The aim is to safeguard the safety and performance of products across the entire life cycle.
By contrast, the Medical Device Regulation (MDR, 2017/745) applies to medical devices in general: implants, aids, diagnostic devices, software — and many of the sample-collection components of a test kit (lancets, microsampling devices, tubes). Both regulations come from the same EU reform wave but cover different product classes.
What a “test kit” is in regulatory terms
A Probatix home-sampling kit is, in regulatory terms, a system of several CE-marked components: collection device, consumables (swabs, tubes, stabilisers), instructions and shipping packaging. Individual components are, depending on their function, either medical devices (under the MDR) or IVDs (under the IVDR). System responsibility — i.e. ensuring that the components function and conform as an assembled product — lies with the system assembler (procedure pack producer under IVDR Art. 22).
For partners this means: you are not buying a bundle of loose parts but a declared IVD system with a documented intended use. Probatix is registered both as a manufacturer (EUDAMED number DE-MF-000054110) and as a system assembler (EUDAMED number DE-PR-000048885). Both roles are maintained in EUDAMED.
Self-test vs. home sampling — the crucial difference
This is the point at which, in public perception, two very different products are almost always conflated:
Self-test: the layperson takes the sample and interprets the result themselves — the result comes about at home, without professional validation. Classic examples: rapid tests, pregnancy tests. Because the layperson is interpreting the result, the IVDR generally classifies self-tests as Class C (higher risk class). Probatix deliberately does not offer such self-tests.
Home sampling (the Probatix model): the layperson only takes the sample at home; the diagnostic analysis is performed in an accredited laboratory; the result is returned as a professionally produced report. Because no lay interpretation takes place, the IVD components of the kit typically fall into Class A of the IVDR (lowest risk class). The sample-collection components fall under the MDR (e.g. rule 22 for the classification of microsampling devices).
Practical consequences of this distinction:
- Diagnostic value — a result from an accredited laboratory is more diagnostically robust than a rapid-test result obtained at home.
- Compliance burden — self-tests are subject to significantly higher requirements for classification, conformity assessment and market surveillance.
- Communication — Probatix kits can be openly described as “sample collection at home, analysis in a specialist laboratory”; they are explicitly not a self-test.
EUDAMED
EUDAMED is the central European database for medical devices and IVDs. It covers several modules — actor registration (manufacturers, system assemblers, importers), product registration with UDI (Unique Device Identifier), vigilance and market surveillance.
Probatix is registered in EUDAMED in two roles:
- Manufacturer — number
DE-MF-000054110 - System assembler / procedure pack producer — number
DE-PR-000048885
For you as a partner this means: you do not need to appear in EUDAMED yourself. The database obligations — actor registration, UDI entry, vigilance — stay with us.
What this means for partners
The regulatory complexity around IVDR, MDR, classification, conformity assessment and EUDAMED is real — and not trivial. Probatix takes on this part as a platform service:
- QMS-backed — our processes run in conformity with ISO 13485 (more in the QMS article).
- Classification handled — you don’t take on an approval project of your own for a standard kit.
- Market surveillance — vigilance, complaints, corrective actions are part of our QMS obligations.
If you want to use your own branded kits under Probatix conformity, that is possible within our framework as a matter of course. If you want to take on a market-placer role yourself, we clarify responsibilities cleanly during onboarding — including who is responsible for which EUDAMED obligations.
Rule of thumb: talk openly with providers about classification, analysis and accreditation. Anyone who dodges these questions has often not done their homework.