If you’re in the medical device industry, you’re well aware of the new EU medical device regulation (MDR) that will come into effect on May 26, 2020 for all device manufacturers selling in Europe.
The new MDR features significant changes — it’s actually four times longer than its predecessor, the Medical Device Directive (MDD).
This EU Medical Device Regulation is a necessary response to technical and scientific developments that are quickly shaping the medical device industry. It’s expected to increase medical device safety and effectiveness in the EU market.
Our main message to you: Don’t panic. Prepare!
Is Your Product Existing or New?
We’ve noticed an uptick in questions from clients and colleagues about the new MDR and how it relates to human factors and usability. These are the two situations we’re seeing most frequently:
Existing Product: I have products that have been on the market in the EU for a long time — do I need to do any additional usability work to make them MDR-compliant?
New Product: I’m introducing a new product to the European market — what do I need to know about the MDR’s usability and human factors requirements?
Luckily, these situations are treated differently under MDR and require different levels of attention, ranging from developing documentation only, to performing some level of usability/human factors testing.
In short, the new EU Medical Device Regulation requires compliance with the international standard on usability engineering (IEC 62366-1:2015), and that standard has separate requirements depending on your situation. MDR will bring increased scrutiny of applications and their usability engineering processes.
Is Your Product UOUP or Non-UOUP?
The next thing to figure out is if your product is UOUP or Non-UOUP, because that will determine how you proceed. If you have an existing product, you’re probably partly to entirely UOUP.
A “User Interface Of Unknown Provenance” is a product that was commercialized before February 2015 and has not undergone any design changes related to the user interface since then. These products have different usability requirements that are primarily documentation-based, and often don’t require additional human factors testing to meet the requirements of MDR.
To many medical device manufacturers with a long history of marketing their products in Europe, this classification sounds like good news.
But be careful — design changes that could trigger Non-UOUP status include something as simple as a labeling change. This is any change made after 2015 that is part of the user interface — so anything the user has to read or interact with in any way. For example, if a manufacturer has changed the kind of plastic used to make an internal component, the device would likely still be UOUP. If they changed the kind of plastic used to make a removable cap, and the new plastic made the cap easier or more difficult to remove, that would be a user-interface-related design change that would trigger Non-UOUP status.
If a design change affects your device as a whole, it may become Non-UOUP entirely. If only a small portion of the user interface has changed, then only that part is considered Non-UOUP, and the requirements listed below apply to that design change only.
For a fully UOUP device, you’ll need to ensure that you have standard human factors documentation including a use specification to define the intended uses, users, and use environments of the device. You’ll need a use-related risk analysis that lists the potential usability issues users may encounter with the device, and maps those issues to user tasks. You’ll also need to ensure that your post-market surveillance data is up-to-date and that any newly identified usability issues are incorporated into the use-related risk analysis.
(You will likely not need a human factors validation study.)
For Non-UOUP devices (or parts of UOUP devices that have undergone design changes), you’ll still need a use specification and use-related risk analysis. Additionally, you’ll need a document called a user interface specification that outlines the associated labelling and training for your device, as well as the “testable technical requirements” (often linked to user needs) of the device.
Finally, depending on the classification of the device, you will need to conduct a human factors validation study. If that’s the case, read on!
Do You Need To Set Up a Human Factors Validation Study for MDR?
Even if you have an existing product that has been on the market in Europe for some time, you probably need some type of human factors work. What does conducting a human factors validation study for MDR compliance entail? Are there different, new requirements?
Below we’ve listed the most frequently asked questions we’ve been fielding from medical device manufacturers about conducting a human factors validation study for MDR compliance. Along with our answers, we’ve included some relevant excerpts from the new European Medical Devices Regulation (MDR).
- This is for European compliance. Do we have to test in Europe?
- How many do we need to test? What should our sample size be?
- Who should we test with?
- What needs to be tested? And how?
1. This is for European compliance. Do we have to test in Europe?
IEC 62366-1:2015 does not specifically require testing in a particular country (like FDA does). So, ask yourself how the product differs in the U.S. versus Europe to determine whether testing in Europe is necessary.
One common example is that there may be nuanced differences between the level of interaction between a nurse and a physician in the EU versus in the U.S. In the EU, a physician may be much more hands on with the entire procedure involving the product, while in the U.S., a nurse and physician may have more of a “tag-team” approach.
2. How many do we need to test? What should our sample size be?
This is a question we often receive, no matter what type of certification the product is seeking – whether it be MDR-compliant CE mark or FDA approval.
Long story short, a 15-participant minimum is generally sufficient to observe use-related error, and both the FDA guidance and IEC 62366-1:2015 for medical device usability engineering make similar suggestions.
3. Who should we test with?
As with devices seeking FDA approval, all relevant groups of representative users should be tested. This requires careful consideration of the intended users and their characteristics (education, diagnosis, physical and cognitive abilities, etc.).
However, the MDR also makes specific reference to “other persons,” which can be interpreted to include personnel who are often overlooked in testing. This is included in the MDR because the regulatory body did not feel as though labeling was being tested with the appropriate users.
Your nurse, physician, or patient might be the obvious choices, but have you considered whether or not your product will be cleaned or disinfected in the hospital? Will it be worked on by a biomed tech? Does your product have a digital interface that integrates with the hospital EMR (hospital IT)?
Here are some selections from the EU Medical Device Regulation that relate to who you should be testing with:
- Section 1.”…shall not compromise the…safety of patient, or the safety and health of users, or the safety and health of users or, where applicable, other persons…”
- Also see Section 14.4. “Devices shall be designed…in such a way that adjustment, calibration, and maintenance can be done safely and effectively.”
The Lay Person
- Section 22.1. “Devices…shall be designed…taking into account the skills and means available to lay persons and the influence resulting from variation that can be reasonably anticipated…The information and instructions provided by the manufacturer shall be easy for the lay person to understand and apply.”
- Also see Section 23.1. “….the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, IFU shall be written in terms readily understood by the intended user and…supplemented with drawings and diagrams.
4. What needs to be tested? And how?
The goal of human factors testing is to ensure that your device is safe and effective for its intended users. In addition to this general objective, MDR outlines specific areas of focus that may have been overlooked by some manufacturers in the past. These areas include the integrity of the packaging (and ensuring that this is obvious to users), digital-physical interactions with the product, and the disposal process (and the description of it in the instructions for use).
Finally, there’s a focus on labeling in MDR. The regulatory document lists all of the required labeling elements, and if your labeling is updated to meet these requirements, you may need to conduct human factors testing to ensure that the new labeling is clear to users.
Here are some selections from the EU Medical Device Regulation that relate to what needs to be tested:
Integrity of Packaging
- Section 11.4. “It shall be ensured that the integrity of the packaging is clearly evident to the final user.”
- Section 14.2. “Devices shall be designed…to remove…a) the risk of injury, in connection with their physical features,…and where appropriate ergonomic features, and d) the risks associated with the possible negative interaction between software and the IT environment within which it operates and interacts.”
- Also see Section 14.6. “Any measurement, monitoring, or display scale shall be designed and manufactured in line with ergonomic principles, taking account of the intended purpose, users, and the environmental condition in which the devices are intended to be used.”
- Section 14.7. “Devices shall be designed…in such a way as to facilitate their safe disposal and the safe disposal of related waste…manufacturers shall identify and test procedures and measures as a result of which their devices can be safely disposed after use. Such procedures shall be described in the instructions for use.”
- Section 21.3. “The function of the controls and indicators shall be clearly specified on the devices…such information shall be understandable to the user and…the patient.”
It’s Worth Repeating: Don’t Panic. Prepare!
If you’re a medical device manufacturer with questions about transitioning from MDD to MDR or meeting MDR requirements for a new device, there’s time to accomplish what needs to be accomplished.
At Bresslergroup we’re performing MDR-related assessments and usability testing on medical devices that were commercialized pre-MDR as well as on new devices. These assessments span a product’s entire usability engineering file and can include generating any of the necessary human factors documentation, including use specifications, use-related risk analyses, and user interface specifications. If you’re not sure what your device requires, please contact us! We’d love to help.
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