Абстракт

Цели: To raise the awareness of professional bodies and national regulators of possible non-compliance with the EU Medical Device Regulations (EU MDR) of some home-use devices being sold with potential safety risks to consumers. Введение: EU MDR Implementing Regulations were published in December 2022 and June 2023 regarding transitional provisions for certain products without an intended medical purpose. During this time there was a high influx of devices with minimal safety features. From the implementation date of transitional provisions, industry observers have noted the appearance in the market of new devices and/or significant changes in existing devices not permitted under regulations. The Transitional Provisions need to be enforced by the European Commission to ensure safety standards are maintained. Материалы / методы: There is disparity between current published standards and the industry standard used by established European manufacturers. This includes the requirement for skin tone sensors and clinical safety and performance studies. The industry standard also includes the Common Specifications requirement for ‘full skin contact’ versus ‘good contact with the skin’ in the current EN standard, where there is an increased risk of eye exposure from intense light flashing in free space. Результаты: APPLiA, the Brussels-based trade association for European home appliance manufacturers, is concerned that these safety features are not standard in newly introduced devices as this is not required by legislation until the end of the transition period in 2028. Examples have been found of possible non-compliances. Заключение: Support is needed from national regulators to enforce EU MDR Transitional Provisions, and safety features should be explained to consumers. APPLiA has published a white paper to reach out to authorities and other professional bodies for support and to actively explain safety features to consumers.