The EU published its Medical Device Regulations on 25th May, 2017. The new regulations were supposed to be imposed from this year but the CoVID-19 pandemic has delayed its implementation, shifting the date of implementation to 26th May, 2021.
The MDR demands that all the medical device manufacturers who want to market their products in the European markets must show compliance with its usability requirements. Of course, transitioning from the previous MDD will take a lot of efforts for the manufacturers therefore it is necessary that the manufacturers should well-familiarize themselves with the new requirements so that they can avoid extra costs and time that will be spent on running extra usability tests.
MDD’s Usability Requirements
The original version of MDD that was released in 1993 had some initial usability requirements. Some amendments were made in 2007 to make it clear that the risks caused due to lack of usability should be minimized. The risks enlisted could be arising from following i.e.:
- Ergonomic features of the device
- The intended environment in which the device is intended to use
- Technical knowledge, experience, and training
- Medical and physical conditions of the intended users (where applicable)
The MDR’s Usability Requirements
The new MDR comes with numerous usability requirements. They are:
Article 5 and Annex I, paragraph 1:
Devices must be suitable for their intended purpose.EU MDR
Article 5 states following regarding the intended use:
“A product should meet all of the safety requirements given its intended use.”EU MDR
MDR Annex I, Paragraph 1
The products should be able to perform in the way specified by their manufacturers given that they are suitable for their intended purpose under normal conditions.
Both (Article 5 and paragraph 1 of the Annex I) refer to the intended purpose which should not only define the purpose of the device but also its intended users and the environment in which the device is intended to use. This is called as “use specification” by the IEC 62336-1 standard. The manufacturers who will not comply with this definition of the intended purpose will not be able to comply with the MDR’s usability requirements.
Annex I, paragraph 3: Analysis of Foreseeable Misuse
The 3rd paragraph of Annex I specifies the usability requirements in the following manner. This part requires manufactures to have a risk management system which should be used to estimate the risks associated with or those which can occur during the intended use or a foreseeable misuse.
This requires a complete analysis of misuse of devices through the post-market data and the data compiled in regulatory basis. All use scenarios should be listed by performing a task analysis and monitoring of users having authorized devices or as a part of cumulative evaluations should be done. The authorities will require results of this analysis to be included within the risk management file.
Annex I, paragraph 5: Measures to Eliminate or Reduce Risks related to or Reduce Risks related to use Errors
In comparison to paragraph 3, paragraph 5 demands for the elimination or at least complete reduction of risks.
The manufacturers are required to reduce the risks that can arise from ergonomic features of the product and the environment in which the product has to be used. Also, the manufacturers should consider the technical knowledge, experience, training and further education along with the physical condition (where applicable) of the intended users.
This makes it mandatory for the manufacturers to define measures for all identified risks that are related to usability. Some examples of these measures are:
- Inherent Safety: A switch that does not exist cannot be used incorrectly.
- Protection Measure: A switch that has a flap that prevents it from being pressed automatically.
- Information for Safety: A warning e.g. in the form of instructions of use, regarding consequences of pressing a switch by mistake.
Annex I, paragraph 14.1: Specific risks from use in combination with other devices:
These risks are also related to usability and result from the interaction of devices with their environment.
This paragraph makes it clear that a product which is to be used in combination with other devices and equipment must be safe for use. Any potential risk associated with combination products should be indicated in the instructions for use. The manufacturer must try to keep all the chances of tasks as low as possible.
It is expected that the manufacturer must have met all the usability requirements. Also, inherent safety against faulty connections should be made less likely to happen as much as possible.
Annex I, paragraph 14.2: Specific Risks Resulting from inadequate Ergonomic Features
The paragraph 14.2 discusses controlling those risks that can arise due to the design of the device. The MDR refers to them as ergonomic features.
According to paragraph 14.2, products should be designed in such a way that risk of injury related to physical properties [i.e. volume/pressure ratio, dimensions and ergonomic features of the product (where applicable) etc.] should either be excluded or minimized.
An example of this can be taken as a dialysis machine that has wheels which due to its heavy mass, can be difficult to stop and can hurt anybody’s feet or hands. Paragraph 14.2 demands these types of risks to be minimized.
Annex I, Paragraph 14.6: Ergonomics of displays
This paragraph of MDR establishes the following usability requirements:
Measuring, control or display devices should be designed in correspondence with the ergonomic principles, intended purpose, intended users and the environmental conditions in which the products will be used.
Since MDR has not defined the ergonomic principles, many manufacturers have begun to define their own style guides. But the manufacturers can look upon ISO 9241 standards which describe every part of user interface i.e. menus, web-pages, command lines etc.
Annex I paragraph 21.3: Understand-ability of Displays
Apart from ergonomic requirements, the MDR requires displays to be understandable too.
The functions of operating and display devices should be clearly indicated on the products. All of the instructions and information should be understandable to the user and if applicable, to the patient.
If the manufacturers want to meet this usability requirement, they must define the attributes of both users and the patients as the understand-ability of a display depends upon the former knowledge of the user.
In order to prove these displays understandable, the help of the empirical data (i.e. in the form of surveys, questionnaires, and post-market data) can be taken.
Annex I, paragraph 22: Lay persons
A lay person is defined by the MDR in following words:
“Lay person means a person who does not have formal education in a relevant field of healthcare or medicine display.”EU MDR
The requirements for lay-persons say that the manufacturers must consider the variations regarding the lay-person’s techniques and environment. The lay person should be able to use the device with safety. The lay person may require training regarding the use of product with safety. The instructions must be easy for the lay person to understand and apply. As per the MDR stipulation, the lay person should be able to use the device as per its intended use. The device should issue a warning if it fails to provide the valid result.
Annex I, Paragraph 23: Usable Instructions for Use
The paragraph 23 specifies the instructions about using the product to be presented in such a way that the intended user can easily understand them. The manufacturers should demonstrate the instructions in the form of diagrams where they feel necessary. Also, they should use internationally recognized symbols at appropriate places as per the MDR’s requirement.
Annex II: Technical Documentation
Annex II establishes contents of the technical documentation as a direct reference to the usability. This should include the definition of intended users, a description which describes that which devices will be connected to the particular device and tests and its results. For software, these tests must be performed in an actual or a simulated user environment. For the device to be connected to other device, proof should be given that the device to be connected must conform to general safety and performance requirements.
Article 83(3) and Annex III section 1.1: Post-market Surveillance
Regarding the post-market surveillance, the manufacturers should check that all the post-market surveillance data is recorded and analyzed. All of this information should be an indicator of improvement in usability and the usability experts as well as risk managers should be involved in the process.
Managing Medical Devices Usability Requirements as per EU MDR
It is comprehensible that management of compliance for medical device usability requirements require expertise and guidance.
TS Q & E is a subject area specialist employing various engineers, and consultants internationally who are well aware of the medical device usability requirements as well as the new EU MDR document. You can contact us through TS Q&E Contact us form and let us know your requirements.