16/17 November 2021
With its new draft guidance on human factors and usability requirements, the MHRA is giving greater emphasis to design process in the development of medical devices and combination products - particularly with regard to the increasing complexity of these products.
The draft comprises 30 pages. Beside the common EU Medical Devices Directives 93/42 EC, 90/385/EEC, 98/79/EC and 2007/47/EC, the norms EN 62366 and 60601 are also referred to. The corresponding paragraphs of those guidelines relating to the topic "Design" are listed in detail in Appendix 3 of the draft.
The document contains an interesting table which usually lists the techniques used for usability studies and brings them in line with the respective stage of the development process. A flow chart illustrates the development process with the "human engineering factors". An own chapter (session 5) is dedicated to them. In this draft guidance, the topic "Usability" is embedded in the lifecycle of the product. Consequently, references to post-market surveillance are made and the conclusions of them with regard to a continuous improvement process.
Although the draft mentions the increasing number of combination products to be expected in future, it contains only a few concrete indications for this group of products. Basically, the device in the combination product is subject to the same expectations regarding the human factors and usability requirements as all other medical devices. Those expectations should be discussed in both the marketing authorisation dossier and in the variations dossier. Any differences between the medical device used in clinical studies and that proposed for marketing should be explained and may require additional human factor engineering studies. The potential medication error of the medical device should be taken into consideration in the risk management plan.
Strictly speaking the MHRA Draft Guidance Human Factors and Usability Engineering – Guidance for Medical Devices Including Drug-device Combination Products applies to Great Britain only, but it is worth reading also for stakeholders from EU Members States, particularly the linking of techniques about manageability studies to each single design stage.