Rules, regulations, and legislations are very necessary to keep the processes running smoothly. The EU has proposed its new Medical Device Regulations (MDR) replacing the old Medical Device Directive (MDD) although the implementation of MDR has been postponed till 26th May, 2022.
The MDR proposes several usability requirements for the medical device manufacturers who are and who wish to market their devices in the European market.
The MDR’s Usability Requirements in Detail
- Considering the intended use of the product, all the basic safety and performances requirements should be met. (MDR Article 5).
- Under the normal conditions, the products should perform in the way that is specified by its manufacturer. The intended use of the product under normal conditions should be considered all the times. (MDR Annex I, paragraph 1)
The manufacturers will be deemed to non-compliant with the MDR’s usability requirements if they fail to produce the intended medical purpose, intended users and the environment in which the device will be used.
The third paragraph of Annex I requires manufacturers to have a risk management system. The 3rd paragraph of Annex I requires the following:
- Research and analysis regarding foreseeable misuse of the medical devices with the help manufacturer’s post-market surveillance data and data present in regulatory databases.
- List of all use scenarios;
- Monitoring of users who are the part of either formative or summative evaluations by using authorized devices
The paragraph 5 of Annex I requires to the elimination of the risks or at least reduction in the chances of risk. MDR defines all the measures that should be taken to identify risks that are related to usability. Paragraph 4 of MDR tells the manufactures to define the inherent safety first, then the protection measures and lastly, the information regarding safety. The example of measures which should be take can be exemplified as follows:
- Inherent Safety: A switch that does not exist cannot be used mistakenly,
- Protection Measure: To prevent a switch from being accidentally pressed upon, a flap is present,
- Information for safety: A warning given in the instructions of use which tells the consequences when the switch is pressed by mistake.
The paragraph 14.1 asks the manufacturers to control the risks arising because of the interactions which the devices establish with their environment. The MDR in paragraph 14.1 also demands inherent safety against the faulty connections present in the devices.
The paragraph 14.2 of the MDR addresses risks which can arise from the design of the device which are addressed by the MDR as ergonomic features of the device. An example of this can be taken as a dialysis machine with wheels. A machine of this type if went out of control, can easily hurt any person coming in contact with it. Its heavy weight as well as high mobility can be a causative agent to hurt a patient or a medical personnel physically.
Paragraph 14.6 establishes the that all of the devices performing the function of measuring, control or display should be designed corresponding to the ergonomic principles, intended users and purpose along with the environment in which they are designed to use. Manufacturers can take guidance from ISO 9241 which describes various aspects of user interface which includes menus, web pages, and command lines etc.
The paragraph 21.3 demands that functions of all the operating and display devices should be comprehensible to users in general and to the patients in particular. How understandable these displays are can be determined by the help of surveys, questionnaires, and post-market data.
Paragraph 22 focuses on the lay-person’s use of a medical device. According to the MDR, a lay-person is the one who does not have any formal education in a relevant field of healthcare or medicine display. While designing a medical device, the manufacturers are required to keep all the techniques and the environment of the lay-person in which he will use the device into consideration. In some cases, the lay-person may require a training so that he can use the device according to its intended use. It should be confirmed by the manufacturers that the lay-person should use the device as per its intended use and the device should be able to issue a warning if it fails to provide a valid result.
Paragraph 23 of the MDR asks the “instructions of use” of a product to be written in such a manner that they are easily comprehensible. Diagrams and illustrations should be drawn where they are needed. The MDR requires internationally recognized symbols to be drawn and presented where they are needed.
Annex II: Technical documentation: annex II requires details of intended users of a device and the other devices which will connect themselves with it. In case of a software, the tests must be performed in a stimulated environment. In case of connecting a device with another device, proofs should be provided that the device conforms to general safety and performance requirements.
The article 83(3) and the section 1.1 of Annex III requires the manufacturers to check and analyze the post market surveillance data thoroughly. This information should serve as an indicator of improvement in usability and should involve usability experts as well as risk managers.