MDR or IVDR: which regulation applies to your product

Does the product examine a specimen taken from the human body, outside the body?

If yes, it is an in vitro diagnostic and the IVDR applies. If no, and it is a medical device at all, the MDR applies. Almost every borderline case is an argument about that one sentence.

Blood, tissue, urine, saliva, swabs — anything derived from the body and examined outside it. The examination must be intended to provide information about a physiological or pathological state, a congenital abnormality, a predisposition, the compatibility with a potential recipient, or the monitoring of therapeutic measures.

The clearest way to hold the distinction: an MDR device does something to or for the patient. An IVDR device tells you something about a sample that came from the patient. A glucose meter measuring a drop of blood is an in vitro diagnostic. A continuous glucose monitor with a sensor in the tissue is not — it never leaves the body, so nothing was examined in vitro.

This is the conceptual difference worth understanding rather than memorising. An MDR device is assessed on the harm it can do to the person using it. An IVD can be dangerous to people who never touch it: a test that fails to detect a transmissible agent in donated blood endangers a recipient, and potentially a population. The IVDR therefore weighs individual risk and public health risk together, which is why the highest class is reserved for tests on transmissible agents and life-threatening conditions with a high propagation risk.

Under the previous directive, the large majority of in vitro diagnostics were self-declared with no Notified Body. Under the IVDR only Class A devices are, and Class A is a narrow category — instruments, receptacles, buffers and washing solutions. The proportion of IVDs requiring a Notified Body inverted, which is the main reason IVDR transition has been harder than MDR transition.

Software is where the line is thinnest. It is not the software that is examined, so ask what it works on. Software interpreting the output of an in vitro examination is governed by the IVDR. Software working on images, vital signs, symptoms or records is governed by the MDR. The endorsed guidance on qualification and classification of software under both regulations is MDCG 2019-11.

A platform doing both is not one product with one answer. Each function is qualified on its own, and a company can end up holding certificates under both regulations.

A test that determines whether a patient is likely to benefit from a specific medicinal product is a companion diagnostic: an in vitro diagnostic under the IVDR, with its own classification treatment and a consultation with a medicines authority. It sits on the border between three frameworks — devices, diagnostics and medicines — and is not a case to resolve from a guide.

Putting an MDR device and an IVD in the same box does not merge the regulations. Each component keeps its own regime, and the person assembling the pack takes on obligations of their own.

Before choosing between the two regulations, confirm that the product is a medical device at all. Lifestyle and wellness applications, general laboratory equipment not intended for diagnostic use, and research-use-only products sit outside both. Getting this wrong in the optimistic direction — assuming you are outside — is the more expensive error, because it means no framework was applied at all.

• —Is it a medical device? If the intended purpose is not medical, neither regulation applies. This is qualification, and it comes before everything else.
• —Does it examine a specimen in vitro? Yes means IVDR, no means MDR. For software, ask what data it acts on.
• —Does it have separable functions? Qualify each one independently before classifying anything.
• —Only then, classify — under the rules of the regulation you have landed in, and against all of them, because the strictest applicable rule prevails in both.

The MDR, Regulation (EU) 2017/745, covers medical devices. The IVDR, Regulation (EU) 2017/746, covers in vitro diagnostic medical devices — those that examine specimens taken from the human body. They were adopted on the same day and share much of their structure, but they have different classification rules and different class labels: I, IIa, IIb and III under the MDR; A, B, C and D under the IVDR.

Ask what it examines. If the device works on a specimen taken from the body — blood, urine, tissue, saliva — outside the body, and its purpose is to provide information about a physiological or pathological state, it falls under the IVDR. If it acts on the patient rather than on a specimen, it falls under the MDR.

It follows the data. Software that interprets the result of an in vitro examination of a specimen is governed by the IVDR. Software that works on other clinical data — images, vital signs, patient records — is governed by the MDR. MDCG 2019-11 is the endorsed guidance on qualifying and classifying software under both regulations.

No. IVDR classes A to D and MDR classes I to III are separate scales built on different criteria. IVDR classification weighs the risk to the individual patient and the risk to public health, which has no equivalent in the MDR. Mapping one onto the other by position produces confident wrong answers.

Not yet. The engine implements Annex VIII of the MDR only. In vitro diagnostics need their own engine because the IVDR rules turn on what a test detects and the consequence of a wrong result, not on invasiveness or duration of contact. It is on the roadmap.