Medical device manufacturers can have a tough time gaining approval of new devices in the US, due to the increased scrutiny of the usability aspects of device design. To some the EU has been seen as a little more “relaxed” when it comes to testing and documenting device usability; the usability engineering process for medical devices is implied and not demanded as part of regulatory submission.
But now, the playing field is levelling out. The standard for Usability/Human Factors ( IEC 62366) was recently updated to IEC 62366-1: 2015. May seem like a subtle difference, yet the content change is significant if you’re developing either a combination product or medical device.
IEC 62366 was closely tied with the Risk Management standard, ISO 14971: 2007 and crammed full of examples of processes and documentation. Until this year, 62366 only required that a Usability Engineering File was created and that usability studies were carried out to verify and validate the safety of the medical device design. Now, however, the usability engineering file must contain results of both formative and summative testing, Summative testing is used to verify and validate the medical device design (IEC 62366-1:2015 subclause 5.9).
There is also now an expectation that summative testing will find use errors that must be analysed, to identify the root cause and determine whether their severity warrants further risk control measures.
Ambiguity over setting study acceptance criteria has been removed at a stroke. Gone are the days when the Human Factors standard used to imply that, for example, a 90% success rate in correctly using the device was acceptable. The focus has now clearly shifted to examining what happened to the 10% who failed to use the device correctly and the consequences for user safety.
All these changes to study design and acceptance criteria requirements will bring EU activities closer to the FDA requirements.
As Europe tightens the usability requirements of medical devices, the only remaining difference between the FDA and the EU is; at what point will the regulators ask to see your Usability Engineering process; pre or post regulatory dossier submission?
If you need help and support or would like a quick chat about your usability engineering programme, get in touch to learn how we can help you improve the usability of your product.