Will the new standard IEC62366-1 simplify market access?
The International Electrotechnical Commission (IEC) has published the first edition of the usability engineering standard “Application of usability engineering to medical devices”. This first edition of IEC 62366-1, together with the first edition of IEC 62366-2, cancels and replaces the first edition of IEC 62366 published in 2007.
Part 1 has been updated to adopt the current concepts of usability engineering but also streamlines the process and is more closely linked to ISO 14971:2007, the standard for risk management for medical devices. Part 2, IEC 62366-2:2016, “Guidance on the application of usability engineering to medical devices”, contains tutorial information to assist manufacturers in complying with Part 1 and provides lots of examples and guidance on how to deal with generating the required deliverables.
The overall structure of the IEC 62366-1:2015 is similar to its predecessor, however, the concept is updated: in the old standard the determination of Frequently Used Functions and Primary Operation Functions where defined as separate process steps whereas in the new standard a more generic Task and Function Analysis is integrated in the early phase of the risk analysis process. This means that already early in the process you will define the Hazard-related Use Scenarios which will serve as a source for the remaining Usability Process Steps.
Another very straightforward and general used development concept is the Sequential Process Steps that define the User Interface Design, Implementation, and Formative Evaluation and is easily integrated into existing medical device design and development processes. The three process steps may be applied in an iterative way; either in the classical V-model or Agile development process.
The Usability Engineering Process ends with a so-called Summative Evaluation of the usability of the user interface: the defined Hazard-related Use Scenarios are evaluated according to a planned protocol. When the defined usability goals are met, only the residual risk still needs to be evaluated according to the risk management process (ISO 14971:2007, 6.4).
Also for legacy products, devices or parts of devices that were already on the market prior to the publication of the standard, a specific process is included. Necessary deliverables to generate during this process are the establishment of a use specification, a review of post-production information, insight in use errors that could lead to hazards or hazardous situations caused by inadequate usability, a review of the risk analysis, the process of identification and documentation of hazards and hazardous situations associated with usability and last but not least the verification and documentation of the implementation of adequate risk control measures for all identified hazards and hazardous situations.
Note: Requirements for usability have also been included in EN ISO 13485: 2016 as Clause 7.3.3a requires design and development inputs to include usability requirements according to the intended use. In addition, also the significance of a change to usability is added to clause 7.3.9 for the control of design and development changes.
What about international harmonization?
Well the IEC 62366-1:2015 is not yet harmonized by the European Union, however, a manufacturer may decide to apply the new standard to show compliance, e.g. when the medical device is also marketed in the US. One way to deal with the situation is to document a rationale in the Summary Technical File that shows compliance with EN 62366:2008 while using IEC 62366-1 data. Another way is to compile a mapping file, that maps each clause of the old standard to (a) matching clause(s) of the new version. All clauses of the old standard need to be covered.
In the United States, the FDA has already recognized the IEC 62366-1:2015 and recognition of IEC 62366:2014 ed. 1.1 will be superseded by the new standard. The FDA will accept declarations of conformity in support of premarket submissions until January 31, 2018. This would be a valid argument to adopt and apply the new standard already now. Another advantage of already applying the new standard is that the content is harmonized with the FDA guidance “Applying Human Factors and Usability Engineering”, issued on: February 3, 2016, so using the new usability standard will streamline FDA premarket submissions in the area of usability engineering, aka Human Factors Engineering. Also for the US compliance to the new standard can easily be created by building a mapping file, using data of the previous standard, that maps each clause of the new standard to (a) matching clause(s) of the old version. Of course also here all clauses of the new standard need to be covered.
Talking about recognition in the United States, a remarkable resemblance can be observed between the content of part 2 of the IEC 62366-2 and the American National Standard ANSI-AAMI-HE75 “Human factors design process for medical devices”, so clearly the International Electrotechnical Commission attempts to align the new standard with this American standard.
What will the future bring?
Currently, manufacturers must use IEC 60601-1-6 and employ the usability process that complies with IEC 62366 to comply with the usability requirement of the general standard. You can never be sure, but what can be foreseen is that at some point in the future the general standard might be revised or amended to include direct references to IEC 62366-1 and that will eliminate the collateral standard.
So, will the new standard simplify market access? Probably, but you have to choose the correct path, the one that eliminates work. If you need any help on deciding which will be the best strategy or in case this blog post raises any questions, please feel free to contact Qserve, we are more than happy to provide assistance with any questions you might have regarding compliance to usability engineering requirements in the United States, Europe or elsewhere.
Written by: Jaap Noordmans, Senior Consultant at Qserve Consultancy