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Medical Devices Intended for Lay Use in the EU

This article was originally published in RAJ Devices

Executive Summary

Medical devices sold over the counter in the European Union for use by lay persons are becoming increasingly complex. High-street shops are offering a growing number of blood pressure monitors, infrared thermometers and other medical technology products that are more complicated to operate, and are associated with higher risks, than traditional “over-the-counter” devices such as simple bandages. These consumer products, however, are often sold without personal advice concerning choice or use, and consumers often must resort to finding out for themselves how to use their purchase on the basis of the enclosed instructions for use.

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