Put simply, it’s the law.
Essential Requirements are enshrined in Europe’s Medical Devices Directive (MDD), which clearly require Human Factors to be considered. If you’re curious to read the text, click here.
As you might expect, similar requirements are described in the Active Implantable MDD (AIMDD) and for IVDs. And for self-test IVDs the requirements are even more specific, as devices must be “easy to use by the intended lay user at all stages of the procedure,” and have reduced as far as practicable the “risk of user error in the handling of the device and in the interpretation of the results.”
For the US market, guidance has been available from FDA for several years and you may recall finalised guidance being published earlier in 2016 (here’s our post about the changes in that document).
European guidance has been notable by its absence.
Until now, that is.
The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has published a draft guidance in June 2016.
The guidance applies to all classes of medical devices, and drug-device combination products that are regulated as medicines.
So whichever submission route you choose, your dossier will be looked at with this guidance in mind. And for those companies looking to supply their newly developed medical technology to the UK’s health service, there’s more; MHRA recommend that NICE and NHS commissioners;
“… investigate and challenge whether appropriate attention has been given to design features of a medical device to ensure safe and effective use in the intended environment.”
Fortunately, the guidance compares well with that from FDA and many similar terms are used. Just as the US moves away from talking about summative usability testing to calling it usability validation, they pass the EU moving in the other direction. However, all is not lost, it’s just a difference in terminology. The underlying requirements and expectations are very similar.
The comment period for this draft guidance closes on 5th August 2016.
You may be unsure what human factors activities are needed for your medical device or combination product. Get in touch today, because it’s never too early to get started on the right path.
Annex 1 of the Medical Devices Directive, Essential Requirements related to Human Factors:
… reducing as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety)” Essential Requirement 1, Annex 1 of the MDD
“the risk of injury, in connection with their physical features, including the volume/pressure ratio, dimensional and where appropriate ergonomic features” Essential Requirement 9.2, Annex 1 of the MDD
“The measurement, monitoring and display scale must be designed in line with ergonomic principles, taking account of the intended purpose of the device.” Essential Requirement 10.2, Annex 1 of the MDD
“Each device must be accompanied by the information needed to use it safely and properly, taking account of the training and knowledge of the potential users, and to identify the manufacturer.” Essential Requirement 13.1, Annex 1 of the MDD
Annex 1 of the In Vitro Diagnostic Medical Devices Directive, specifically relating to Self Test IVDs:
‘ER 7.1. Devices for self-testing must be designed and manufactured in such a way as to:
- ensure that the device is easy to use by the intended lay user at all stages of the procedure, and
- reduce as far as practicable the risk of user error in the handling of the device and in the interpretation of the results.
ER 7.2. Devices for self-testing must, where reasonably possible, include user control, i.e. a procedure by which the user can verify that, at the time of use, the product will perform as intended.’