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Honda Walking Assist Obtains Medical Device Approval in the EU
Honda Motor Co., Ltd. today declared that the Honda Walking Assist Device(1), an assistive device for use in the training and rehabilitation of walking, has obtained the Medical Devices Directive (Council Directive 93/42/EEC) certification, which allows Honda to affix the CE marking and commercialize the device within the European Union (EU) countries.
Conformity with EU standards (EU Directives) and affixing the CE marking on the product, a certification mark that specifies conformity with EU standards, are compulsory in order to distribute and sell the product in EU countries. Various products including machinery, electrical equipment designed for use within certain voltage limits (low voltage) and toys are subject to EU directives, and the Medical Devices Directive (MDD) sets harmonized standards for medical devices, and conformity with the Directive certifies the manufacturer to affix the CE marking on a product.
The Honda Walking Assist Device obtained an MDD approval and CE marking as a medical device which comply with standards mandated by the MDD, enabling Honda to apply the CE marking on the Walking Assist Device.
Moreover, the Honda Walking Assist Device became the first case of MDD approval that was obtained through a cooperative approach between the Japan Quality Assurance Organization (JQA), a Japan-based third-party ISO certification organization, and TUV Nord Cert GmbH(2), a German-based third-party certification organization, which leveraged assessment and certification based on the ISO 13482 certification(3) that the Honda Walking Assist Device had already obtained.
With this MDD approval, Honda today (on January 18, 2018) received the MDD certificate from TUV Nord Cert GmbH in the presence of the JQA.
While continuing its research and development efforts since 1999, Honda began lease sales of the Honda Walking Assist Device in November 2015 to organizations and businesses in Japan as an assistive device for use in the training of walking. As of today, the Honda Walking Assist Device is being used at almost 250 facilities throughout Japan to assist training of walking and measure walking ability.
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