UK MHRA Ensures There Is ‘No Avoiding' Usability Engineering
Changes the UK regulator has made to its guideline on human factors and usability engineering make the document more useful and realistic, and bring it in line with international standards, says a UK-based consultant.
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After some five years of working on the EU's new Medical Devices Regulation and IVD Regulation, the texts that were finally adopted on April 5, have been published in the Official Journal of the European Union.
The UK Medicines and Healthcare products Regulatory Agency is inviting feedback on a draft guideline on human factors and usability engineering to clarify its expectations on this front under the current and future EU medical device legislation1,2.