IVDR and Usability – do they belong together?

Do you have to do Usability Engineering to get the clearance of your IVD? If so, how can you ensure that it is done in accordance with the regulations? What does the IVDR require regarding the Usability of an IVD? When do the requirements of the IVDR come into effect?

We are often asked these questions. This is only understandable, because the IVDR, i.e. the In-vitro-Diagnostic Device Regulation, , does not use the word „Usability“ at all.

In this article, we will provide you with all the answers to the above questions and show you the parts of the IVDR that you need to know in order to properly approach Usability Engineering for your IVD.

What does the IVDR mean for you?

There is a Usability Obligationfor medical devices. But what about IVDs? These are subject to the IVDR.

The IVDR, the EU’s new regulatory framework for IVDs, came into effect on May 25, 2017. A five-year transition period was decided here, during which developers can switch from the IVDD to the IVDR. The effective date of the IVDR is thus May 26, 2022, and the transition periods for products already on the market were only recently extended. If you want to launch a new product on the market, you are bound by the IVDR.

For you as a manufacturer of IVDs, this changes a few basic things compared to the IVDD:

• Instead of 24, you must now consider 113 articles.
• The IVDR regulates the development, use and also the market surveillance and import of IVDs.
• It provides “general safety and performance requirements” that you must prove compliance with.
• This proof happens via the conformity assessment procedure.

The IVDR now establishes new classes for IVDs that determine what requirements you, as a manufacturer, must meet for your IVD. Important to know: all classes are required to do so under the IVDR:

• To demonstrate suitability for use according to IEC 62366-1.
• To develop closely with risk management according to ISO 14971.
• To demonstrate verification and validation of the product.

There are now 4 classes for IVDs. Ascending by criticality:

Class A: All non-critical products fall into this class. Class A products entail at most a very low risk. These mainly include instruments and sample containers for laboratory use. A distinction is made between sterile and non-sterile products.

Class B: With Class B IVDs, slightly critical readings are collected. Misdiagnoses do not have life-threatening risks. This can be, for example, a measuring device for blood glucose.

Class C: Critical measurements, such as infectious diseases or drug dosages, fall into Class C. Misdiagnosis of a Class C IVD is associated with life-threatening risks. An example would be an EGF receptor in lung cancer.

Class D: This class contains highly critical measured data. For example, for determining highly infectious and potentially fatal diseases. HIV tests fall into class D. In the future, SARS-CoV-2 tests, which are very present in our current daily lives, will also fall into this category.

The higher the class, the higher the regulation of the product by the IVDR. For class A (not sterile), a conformity assessment with preceding technical documentation is sufficient.

In addition, the IVDR distinguishes between three types of IVDs:

Near Patient Testing: These are IVDs that are used by a healthcare worker near the patient or on the patient. These include IVDs used in ambulances or the emergency room.

Selftests: This includes all IVDs that are used by laypersons. This can be a blood glucose meter, but also a Corona self-test.  

Companion Diagnostics: Also called CDx. These often test the effect of certain drug treatments.

Specific case: software. The decisive factor here is the intended use of the software. If it is used for medical purposes, it is considered an IVD.

At which stage do Notified Bodies come into play?

The new classifications are also accompanied by stricter requirements for the products. For example, all products from Class B upwards must be examined by a Notified Body in order to obtain approval.

This is a rapid increase: A study shows that the Notified Bodies involved have increased from 7% to 84%! (source).  Approximately 80% of devices did not require a Notified Body under the IVDD. The IVDR now means that only about 20% of devices will not need a Notified Body (source). The need for Usability Engineering for IVD products has thus increased dramatically.

What does this mean for you as an IVD manufacturer?

In addition to analytical sensitivity, analytical specificity, and accuracy and precision of the measurement, manufacturers must demonstrate even more in their technical documentation.

Namely, a specification of what the product is supposed to do. It must also be comprehensibly justified how it is to be ensured that the product also achieves these things specified before. In doing so, you must demonstrate the exclusion of unacceptable risks during use. In short: You need good and safe Usability!

So what are you indirectly being asked to do?

• Usability Research
• Usability Engineering
• Proofing both with a Usability Engineering File.

If your product is already on the market, it is sufficient to prove that you have performed a root cause analysis for your product (and, if applicable, for comparable products on the market) and that you have provided evidence of this in the form of a Usability Engineering File.

If you want to know how to prepare the Usability Testing for your IVD we recommend our article “How to prepare your Usability Testing for IVDs“.

The transition periods from the IVDD to the IVDR:

The transition periods for your IVD depend on the class of your IVD:

• Class A (non-sterile products): here, there is no extended deadline.
• Class A (sterile products): here, you have until May 26, 2027 to upgrade from the IVDD to the IVDR.
• Class B: again, the deadline is May 26, 2027.
• Class C: products in this category have a deadline of May 26, 2026.
• Class D: Here, the deadline is May 26, 2025..

Where exactly is the Usability of an IVD regulated by the IVDR?

Let’s now take a look at the relevant passages. Even though the word “Usability” does not appear once, the following points are all tasks of Usability Engineering, respectively Usability Testing.

Annex 1: chapter 1: 5a and b

The “reduction of risks due to application errors” is addressed here. Manufacturers are given the following requirements here:

• Reduction of possible risks through ergonomic features of the product and the environment in which the product is going to be used.
• Manufacturers have to: “give consideration to thetechnical knowledge, experience, training and use environment, where applicable, and the medical and physical conditions sowie die of intended users (design for lay, professional, disabled or other users).”