Classification of in vitro diagnostic devices (IVD)

In vitro diagnostic (IVD) devices – medical devices that are not regulated under MDR. This is because the EU In Vitro Diagnostics Regulation (IVDR) applies here. But which medical devices fall under the term IVD? What is the classification of the product? And what obligations do manufacturers have to observe?

According to Article 2 of Regulation (EU) 2017/746 (IVDR), the term means “a medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, device, software or system, whether used alone or in combination, intended by the manufacturer to be used for the in vitro examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information […]”.

Source (in german)

Information about what? This includes, following the regulation,

physiological or pathological processes
congenital physical or mental impairments
susceptibility to certain diseases, etc.
determining whether potential recipients show any concerns or intolerances
an anticipated effect or reaction to a treatment
the determination or monitoring of therapeutic measures

How does the classification work?

The classification of an IVD is also regulated in the IVDR within the framework of risk-based classification. As in the Medical Device Regulation (MDR), the classification is based on the intended purpose of the product and the resulting risk profile. According to the IVDR, the classification is made into classes A, B, C and D.

The IVDR defines the risk class of a product on the basis of seven rules. If there is a low risk, products are assigned to class A. As the risk increases, products are assigned to classes B, C or D. Only for medical devices in class A is it possible for manufacturers to declare conformity themselves for market placement; for the other risk classes, the notified bodies must be involved in the conformity assessment procedure.

Good to know

According to the IVDR, the accessories for an IVD are classified separately. The risk class of the associated device is to be considered independently of the classification of the accessory. (cf. Annex VIII, 1.3)

If several classification rules apply to a product, the IVD is assigned to the highest risk class. The same applies if the manufacturer specifies several intended uses for a product and the product can thus be assigned to several classes. In this case, too, the classification is made in the highest risk class.

The classifier for in vitro diagnostic devices: New function in BAYOOSOFT Risk Manager 10.4

With Risk Manager Version 10.4, the functions of the already established classifier for medical devices are also available in conformity with the IVDR 2017/746 standard. Thus, you determine the assignment of the risk class in an uncomplicated way by answering predefined questions. Features for labelling and recognition of non-applicable questions are also included to ensure conformity with your notified body.

product presentation

What are the obligations of IVD manufacturers?

When products are placed on the market and put into service, manufacturers ensure conformity according to the IVDR with the technical documentation. In addition, the IVDR – similar to the MDR – requires the establishment and implementation of a risk management system and technical documentation for the medical device.

Both must be continued and maintained even after the device has been placed on the market. At the request of the Notified Bodies, the technical documentation, among other things, must be handed over for at least ten years after the device has been placed on the market.

Get to know us

The efficient way to technical documentation: BAYOOSOFT Risk Manager supports you in the creation of technical documentation for medical devices and in vitro diagnostics. All relevant information is recorded in a clearly structured environment, stored centrally in an audit-proof manner and linked dynamically in a fine-granular manner. This automatically avoids redundant data storage. Reports are generated with the most up-to-date data at the touch of a button.

Would you like to get to know the BAYOOSOFT Risk Manager? Then take advantage of our 30-day free TRIAL or visit one of the upcoming online product presentations. You can find an overview of upcomming events here.

Classification of in vitro diagnostic devices (IVD)

How does the classification work?

The classifier for in vitro diagnostic devices: New function in BAYOOSOFT Risk Manager 10.4

What are the obligations of IVD manufacturers?

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