The British Standards Institution (BSI) recently amended BS EN 62366-1:2015 standard — Medical devices. Application of usability engineering to medical devices. The BS EN 62366-1:2015+A1:2020 became effective in August 2020. The document is aimed at helping manufacturers of medical devices and systems to work out the good usability engineering process that is focused on the identification and minimization of the use-associated risks. With this process, the manufacturer will be able to specify, develop, and estimate the usability of a medical device with regards to its safety application.
Moreover, the standard connects with the BS EN ISO 14971:2019 - Medical devices. Application of risk management to medical devices as to methods of risk management on safety use.
This British standard is harmonized with the international standard IEC 62366-1:2015/AMD1:2020 - Medical devices - Part 1: Application of usability engineering to medical devices that came into force in Europe in July 2020.
Please note that national product marking and conformity assessment requirements for medical devices should be taken in consideration by the manufacturers that want to place the products on the Great Britain market generally from January 1, 2021.
The information has been prepared by the GMA Consult Group team. GMA Consult Group provides a full cycle of international type approval and global market access services for IT, Telecom and industrial electrical products in all countries throughout the world. With proven expertise in worldwide regulations, compliance, certification, and conformity assessment, GMA Consult Group can help your company speed up the access to any market with almost zero efforts from your side.
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