What Does “State of the Art” Actually Mean in the EU MDR and IVDR?
It’s understandable. Most of us think of “state of the art” as describing the latest and most advanced stage of a technology. For example, most people would consider a solar-powered pacemaker to be state of the art. (Don’t hold your breath for this one to come to market.) Yet, this notion of state of the art isn’t what is meant in the context of the EU MDR, IVDR, and risk management. As such, manufacturers often face challenges in assessing state of the art in design and postmarket surveillance. Some of the confusion arises because, in the medical device and IVD regulatory arena, “state of the art” refers only to products that are developed and approved for sale in the marketplace. As we all know, there is a very big difference between a new state-of-the-art digital imaging system that is undergoing trials and one that already has CE Marking. For EU medical device regulators, the latter is considered state of the art, but the former is not until it has CE Marking.
Here’s one way to think about this. Ask yourself, “What is state of the art in cars these days?” You might reply self-driving cars, or a Tesla. But the reality is that these are highly innovative and don’t represent the “developed” stage of technology. State of the art is really the middle of a bell curve in innovation. A Model T certainly isn’t state of the art, but cars with airbags, power steering, and even backup cameras could be considered state of the art under the ISO 14971:2019 3.28 definition. Read more about the changes to ISO 14971:2019 here.
A note associated with this definition from MEDDEV 2.7/1 rev 4 adds more insight: “The state of the art embodies what is currently and generally accepted as good practice. The state of the art does not necessarily imply the most technologically advanced solution.” Thus, it is more useful to think of state of the art as meaning “the current state of all competitive treatment options.”
What does “Good Practice” Really Mean?
If your medical device or IVD is not the most technologically sophisticated product on the market but has a sparkling safety record, possesses solid clinical data, and follows all the latest standards, does that mean it still meets best practices and qualifies as state of the art in the eyes of EU regulators?
It also depends on the benefit-risk balance over the life of the device. As the device ages, assuming no new versions are introduced, it becomes less state of the art (like a Model T). It also has less benefit as newer treatment options are developed. Even if the risk profile is unchanged for your device, there will be less risky devices on the market.
Your Notified Body Will Be Looking at the Analysis in Your Technical Documentation
In the new EU MDR and associated MEDDEV 2.7/1, you are expected to demonstrate that you have conducted a thorough analysis of the current state of the art. Notified Bodies are increasingly looking to see that you have performed an in-depth assessment of alternative treatment methods for the same indications – thus, you can expect more scrutiny during your next surveillance audit.
You are required to take state of the art into account when assessing the risk acceptability of your devices, adopting risk control measures, and assessing the clinical benefit of your devices. As such, state of the art is critical in assessing the benefit-risk ratio of the device, and you need to take it seriously in your clinical evaluation report (CER). If your device has been on the market for decades and there are two devices that are technically superior and present lower risk than yours, they reduce the benefit of your device and increase the risk side of your benefit-risk equation.
MEDDEV 2.7/1 rev 4 clarifies the definition and objectives for establishing state of the art, and also provides guidance on content and methods. MEDDEV 2.7/1 describes state of the art as current knowledge in the corresponding medical field, such as applicable standards and guidance documents, information related to the medical condition managed with the device, and its natural course, benchmark devices, or other devices and medical alternatives available to the target population. Description of state of the art provides a framework for manufacturers and Notified Bodies to assess the device’s safety and performance.
In the new IVDR, it is required that manufacturers specify and justify the level of clinical evidence necessary to demonstrate conformance in view of the device characteristics and intended purpose. Clinical evidence, performance evaluation, and study requirements for IVDs are defined related to the state of the art in medicine. Clinical evidence should demonstrate, with reference to state of the art, that clinical benefit will be achieved and that devices are safe.
Interested in Learning More?
One of our most popular training courses focuses on medical device risk management. Recently updated for ISO 14971:2019, this course takes a deep dive into all things risk and covers risk-related issues in the MDR, MDSAP, CERs, and (of course) ISO 14971. We also offer this very popular EU MDR training course and one focused on the IVDR.