Manufacturers must demonstrate compliance with the MDR's usability requirements for all medical devices without exception.
For some devices, there are transitional periods. Nevertheless, manufacturers would be well advised to familiarize themselves with the differences between the MDD's and the MDR's requirements with regard to usability. That's the only way to manage the transition to the MDR smoothly and avoid regulatory hassle and costs, e.g., from unnecessary usability tests.
Our free checklist will help you to quickly make sense of it all and identify the measures necessary, even for “legacy devices”.
The original version of the Medical Device Directive (MDD, 93/42/EEC) already contained some initial usability requirements. For example, “measurement, monitoring and display scale[s]” had to be “designed in line with ergonomic principles”.
The amending directive 2007/47/EC added to the MDD the explicit essential requirement that risks caused by a lack of usability must be minimized. It already differentiated between risks arising from the
In parallel with this amendment, the EU harmonized the standard EN IEC 62366:2006, which, from then on, represented the state of the art.
Searching the EU Medical Device Regulation (MDR) for the term “usability” returns surprisingly few hits. Nevertheless, the EU regulation contains numerous usability requirements.
Article 5 and the first paragraph of Annex I (General safety and performance requirements) of the MDR establish very similar requirements:
Ein Produkt muss unter Berücksichtigung seiner Zweckbestimmung den in Anhang I festgelegten für das Produkt geltenden grundlegenden Sicherheits- und Leistungsanforderungen genügen.
Die Produkte erzielen die von ihrem Hersteller vorgesehene Leistung und werden so ausgelegt und hergestellt, dass sie sich unter normalen Verwendungsbedingungen für ihre Zweckbestimmung eignen.
Both refer to the intended purpose. This intended purpose should not just define the intended medical purpose, it should also define the intended users and the environment in which the device is intended to be used. IEC 62366-1 calls this the “use specification”.
Read more on what an intended purpose should include here.
This means that manufacturers who have not precisely defined this intended purpose and, therefore, have not defined the intended users and the environment in which the device is intended to be used will find it very difficult to comply with the MDR's usability requirements.
The first paragraph of Annex I makes providing this proof mandatory.
The third paragraph of Annex I on general safety and performance requirements contains even more specific usability requirements:
It requires manufacturers to have a risk management system. They must use it to “estimate and evaluate the risks associated with, and occurring during, the intended use and duringreasonably foreseeable misuse”.
This risk analysis must correspond to the state of the art. Pure speculation is, therefore, not enough. In fact, the following would be expected:
An auditor or a regulatory authority would expect the results of this analysis to be in the risk management file.
The authors of the MDR have copied paragraph 5 from the MDD almost to the letter:
Beim Ausschluss oder bei der Verringerung der durch Anwendungsfehler bedingten Risiken müssen die Hersteller
a) die Risiken aufgrund ergonomischer Merkmale des Produkts und der Umgebung, in der das Produkt verwendet werden soll, so weit wie möglich verringern (auf die Sicherheit des Patienten ausgerichtete Produktauslegung) sowie
b) die technischen Kenntnisse, die Erfahrung, die Aus- und Weiterbildung, gegebenenfalls die Anwendungsumgebung sowie die gesundheitliche und körperliche Verfassung der vorgesehenen Anwender berücksichtigen (auf Laien, Fachleute, Behinderte oder sonstige Anwender ausgerichtete Produktauslegung).
MDR, Annex I, paragraph 5
While paragraph 3 required the analysis of usability risks, paragraph 5 calls for their elimination, or reduction at least.
As a result, the MDR makes it mandatory for manufacturers to define measures for all identified risks related to usability. According to paragraph 4, manufacturers must first aim for inherent safety, then aim for protection measures and, only after that, provide information for safety.
Examples of these measures are:
Paragraph 14 requires risks resulting from the interaction of devices with their environment to be controlled. These risks are also, in part, related to usability:
Wenn ein Produkt zur Verwendung in Kombination mit anderen Produkten oder Ausrüstungen bestimmt ist, muss die Kombination einschließlich der Verbindungen sicher sein und darf die vorgesehene Leistung der Produkte nicht beeinträchtigen. Jede Einschränkung der Anwendung im Zusammenhang mit solchen Kombinationen wird auf der Kennzeichnung und/oder in der Gebrauchsanweisung angegeben. Vom Anwender zu bedienende Verbindungen, wie etwa die Übertragung von Flüssigkeit oder Gas oder elektrische oder mechanische Verbindungen, werden so ausgelegt und hergestellt, dass alle möglichen Risiken, wie etwa fehlerhafte Verbindungen, so gering wie möglich gehalten werden.
MDR, Annex I, paragraph 14.1
These usability requirements in the MDR should already have been met if the manufacturer has considered all use scenarios, including scenarios in which their device is combined with and connected to other devices. The MDR also demands here, as of a measure, inherent safety against faulty connections as far as possible.
Paragraph 14.2 looks at another type of risk. Unlike paragraph 14.1, it requires risks relating to the design of the device to be controlled not risks resulting from misuse. The MDR refers to “ergonomic features”:
Die Produkte werden so ausgelegt und hergestellt, dass folgende Risiken ausgeschlossen oder so weit wie möglich reduziert werden:
a) Verletzungsrisiken im Zusammenhang mit den physikalischen Eigenschaften einschließlich des Verhältnisses Volumen/Druck, der Abmessungen und gegebenenfalls der ergonomischen Merkmale des Produkts;
MDR, Annex I, paragraph 14.2
An example would be a dialysis machine on wheels. Due to its weight, a rolling dialysis machine would be difficult to stop and could cause bruising to someone's feet or hands. This is exactly the type of risk that manufacturers must minimize.
Paragraph 14.6 of the MDR also establishes usability requirements.
Mess-, Kontroll- oder Anzeigeeinrichtungen werden so ausgelegt und hergestellt, dass sie mit Blick auf die Zweckbestimmung, die vorgesehenen Anwender und die Umgebungsbedingungen, unter denen die Produkte verwendet werden sollen, ergonomischen Grundsätzen entsprechen.
MDR, Annex I, paragraph 14.6
But the MDR does not explain what ergonomic principles actually are. As a result, a lot of manufacturers are starting to define their own style guides and, to a large extent, reinvent the wheel over and over again.
The Johner Institute recommends using the specifications found in the ISO 9241 family of standards. These standards describe, in concrete terms, how user interfaces - from menus to web pages to command lines - should be designed.
Please note: The effects on the design of user interfaces must take the use environment (e.g., brightness, distance from the device) as well as the users (e.g., physical impairments) into account.
In addition to ergonomic requirements, the MDR also requires displays to be understandable:
Die Funktion von Bedienungs- und Anzeigeeinrichtungen wird auf den Produkten deutlich angegeben. Sind die Anweisungen für die Anwendung des Produkts auf diesem selbst angebracht oder werden die Betriebs- oder Regelungsparameter visuell angezeigt, so müssen diese Angaben für den Anwender und gegebenenfalls den Patienten verständlich sein.
MDR, Annex I, paragraph 23.1
In order to meet this MDR usability requirement, manufacturers must define the characteristics of the users and the patients precisely. Because whether a display is understandable or not depends on the prior knowledge and experience of the specific user.
Whether these displays are really understandable as part of the user interface can only be proven by empirical data. Manufacturers can collect this data through, for example, surveys, participant observations or post-market data.
The specific and extensive requirements contained in the MDR regarding safe use by lay persons are new in this form. The regulation even defines the term:
“‘lay person’ means an individual who does not have formal education in a relevant field of healthcare or medical discipline;”
Because the requirements are so extensive, here is a summary:
These requirements have a direct effect on the design of the device, as well as on the design of training courses and the evidence required, e.g., in the form of usability tests.
The MDR does not limit its requirements to the device itself. The instructions for use and other accompanying materials must also be usable.
Medium, Format, Inhalt, Lesbarkeit und Anbringungsstelle der Kennzeichnung und der Gebrauchsanweisung eignen sich für das jeweilige Produkt, seine Zweckbestimmung und die technischen Kenntnisse, die Erfahrung, Ausbildung oder Schulung der vorgesehenen Anwender. Insbesondere ist die Gebrauchsanweisung so zu verfassen, dass sie von dem vorgesehenen Anwender ohne Schwierigkeiten verstanden wird, und gegebenenfalls mit Zeichnungen und Schaubildern zu ergänzen.
MDR, Annex I, paragraph 23.1 c)
Manufacturers are not entirely free to implement these requirements as they see fit. For example, the MDR requires them to use internationally recognized symbols and to describe them where necessary.
Even Annex II contains a direct reference to usability because it establishes the contents of the technical documentation. This should include:
For software, these tests must be performed in a “simulated or actual user environment”.
If the device is intended to be connected to another device, “proof that it conforms to the general safety and performance requirements when connected to any such device(s) having regard to the characteristics specified by the manufacturer” must be provided.
The only time that the MDR uses the term “usability” is in the context of the UDI (not relevant here) and the post-market surveillance.
The MDR expects manufacturers to use “data gathered by the manufacturer's post-market surveillance system” in particular:
f) Ermittlung von Möglichkeiten zur Verbesserung der Gebrauchstauglichkeit, der Leistung und der Sicherheit des Produkts;
MDR, Article 83(3)
In Annex III, the MDR then specifies which information has to be collected and analyzed:
– Informationen über schwerwiegende Vorkommnisse, einschließlich Informationen aus den Sicherheitsberichten, und Sicherheitskorrekturmaßnahmen im Feld,
– Aufzeichnungen über nicht schwerwiegende Vorkommnisse und Daten zu etwaigen unerwünschten Nebenwirkungen,
– Informationen über die Meldung von Trends,
– einschlägige Fachliteratur oder technische Literatur, Datenbanken und/oder Register,
– von Anwendern, Händlern und Importeuren übermittelte Informationen, einschließlich Rückmeldungen und Beschwerden und
– öffentlich zugängliche Informationen über ähnliche Medizinprodukte.
For manufacturers this means:
Manufacturers developing new devices should follow IEC 62366-1. This standard describes the state of the art.
In contrast, manufacturers of devices that have already been developed and that either have to be re-authorized or that benefit from transitional periods should evaluate the conformity of their devices again.
This does not necessarily require a complex conformity assessment. The Johner Institute’s checklist (see below) will help quickly provide some initial clarity.
Systematically collecting post-market data and analyzing it for indications on how to improve usability is an unavoidable obligation. This requires suitable processes, tools and experts.
In summary, the Johner Institute makes the following recommendations:
Careful! Manufacturers of devices that benefiting from the transitional periods should not sit back and relax on the assumption that conformity with the MDD is a given and sufficiently proven. The state of the art and risk management forces manufacturers to de facto comply with the MDR requirements, even though the MDD never worded these requirements as explicitly.
The Johner Institute has prepared a checklist that manufacturers can use to give themselves a quick overview of whether their devices and processes comply with the state of the art and the MDR's requirements.
The Johner Institute's usability experts will help you to quickly identify deviations and to establish the perfect measures for closing these gaps.
Tasks that the Johner Institute can support you in are:
The Johner Institute's experts focus on avoiding any type of unnecessary work and work on a risk-based basis. They work with you towards the aim of ensuring safety for patients and confidence for your company during when it comes to authorization audits.
Tasks that the Johner Institute can support you in are:
The Johner Institute has already performed post-market surveillance for some manufacturers as part of a beta program. This service will soon be offered to other manufacturers.
A first look at the MDR is deceptive. You shouldn’t conclude that usability is not a concern for the MDR just because the EU regulation barely uses the term “usability”. In fact, the opposite is true. As explained in the article above, it establishes extensive usability requirements.
Unfortunately, the MDR uses terms like “ergonomics” (like the German Digital Healthcare Applications Ordinance (DiGAV)), but does not use established definitions.
Manufacturers of devices that are still placed on the market with MDD certificates should not sit back and relax either. The MDD also demands the state of the art. The MDR just defines this state of the art more explicitly.
The Johner Institute recommends that manufacturers should
Make sure that their post-market surveillance system is effective and conforms to the requirements. Because there are no(!) transitional periods for this.