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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?
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).”
Annex 1: chapter 2: 11.1a
Products and manufacturing processes must be designed in such a way that a risk of infection by users and third parties can be excluded. If this cannot be guaranteed, it must be demonstrated that the risk is as low as possible. In this context, IVDs must be designed to “allow easy and safe handling.” In other words, the product needs good Usability.
Annex 1: chapter 2: 13.7
Here the requirement is: Measuring, control and display equipment (i.e. interfaces) “shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users and the environmental conditions in which the devices are intended to be used”. Thus, Usability Research must take place to match the application to the user and environmental conditions.
Annex 1: chapters 2: 15.3
Here we are talking about instructions for use for devices that emit hazardous or potentially hazardous radiation. These instructions for use should ensure that users manage to “avoid incorrect use” and to “reducing the risks inherent to installation as far as possible and appropriate”. In the course of Usability Research, it must therefore be established and proven that users are able to avoid incorrect use and installation-related risks with the aid of the instructions for use.
Annex 1: chapter 2: 16.3
Chapter 16 deals with all IVDs that consist in components of programmable electronic systems or are products in the form of a software. For these devices, 16.3 requires that specific properties of the interface (e.g., size and contrast ratio of the screen) be matched to the external factors that affect use (lighting conditions, noise level). All these factors are also found out during Usability Research and considered in Usability Engineering. In other words, if you do Usability Engineering for your product, you ensure that the properties of the interface are optimally tailored to the usage environment.
Annex 1: chapter 2: 18.7
This paragraph requires you to design parts of your product that are intended to be connected to energy sources so that risky errors during assembly are ” made impossible by the design and construction of such parts or, failing this, by information given on the parts themselves and/or their housings”. Again, Usability Engineering must be demonstrated here for compliance.
Annex 1: chapter 2: 19.1
Sub-item 19 of Annex 1 of the IVDR deals with protection against the risks posed by devices intended for self-testing or near-patient testing. In 19.1, there are a variety of requirements for your product, all of which are resolved during the Usability Engineering process.
- Products intended for self-use or near-patient testing must be designed to operate error-free according to the capabilities and capabilities of the intended users.
- Effects of expected variations must also be included.
- Product information and instructions must be easy to understand and apply. This ensures that the result can be interpreted correctly. Misleading information must also be avoided.
- Training and qualification of the users as well as the level of experience must also be included here when it comes to the information and instructions.
Annex 1: chapter 2: 19.2
Here it is required that “the device can be used safely and accurately by the intended user at all stages of the procedure if necessary after appropriate training and/or information”. The risk of incorrect handling of the product or misinterpretation of the results should also be kept as low as possible.
These are also issues that can be clarified during Usability Engineering and whose solution can thus be verified.
Annex 1: chapter 2: 19.3
In this subitem, you are required to ensure that the intended users of your IVD can verify for themselves whether the product works as intended when used. The product must also include a warning to the user, should a valid result not have been obtained during use.
To prove that your product can do this, you need data from real users from Usability Tests.
Annex 1: chapter 3: 20.1
Subitem 20 is devoted to “Requirements regarding information supplied with the device”. 20.1 requires you to:
- Match the labeling and instructions for use to the product in question.
- Likewise, these instructions must match the intended purpose of the product.
- Instructions must also be adapted to the technical knowledge, experience, education or training of the intended users.
- ” In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.”
You can prove that you have fulfilled this purposefully with Usability Testing.
Annex 1: chapter 3: 20.4.2
20.4.2 devotes almost 30 subsections to the information that must be contained in the instructions for use. You can credibly prove that you have successfully implemented all these sub-points by means of Usability Engineering & Testing.
Usability and IVDR belong together, even if the word Usability is not explicitly mentioned. The subsections listed show you that there is no way around Usability Engineering. But with the right approach and the right partner, you can confidently implement the requirements of the IVDR for your in-vitro product.
For your preparation for the Summative Evaluation according to IVDR, we have prepared a Checkliste samt Erklärungen for you here.
What is your specific case? Comment on this post or get in touch via our contact form. We look forward to hearing from you.