Honda Walking Assist Obtains Medical Device Approval in the EU
January 18 2018 - 2:25AM
JCN Newswire (English)
Honda Motor Co., Ltd. today announced 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
enables 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 indicates
conformity with EU standards, are mandatory 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 approximately 250
facilities throughout Japan to assist training of walking and
measure walking capability.
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Honda Walking Assist Device
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Honda Walking Assist Device in use
(1) The Honda Walking Assist Device is a device designed for the
purpose of assisting the person who wears it in walking
rehabilitation. In Japan, it is not approved as medical equipment
designed for the purpose of diagnosing, treating or preventing a
disorder of the user.
(2) TUV Nord Cert GmbH is an international third-party
certification organization headquartered in Hannover, Germany. TUV
Nord Cert GmbH operates in approximately 70 countries and regions
around the world.
(3) The International Organization for Standardization (ISO) issued
ISO 13482 in 2014 as the only international safety standard for
personal care robots (living-support robot) in the world. The Honda
Walking Assist Device obtained the ISO 13482 certificate in October
2015.
About Honda
Honda Motor Co., Ltd. (TSE:7267 / NYSE:HMC / LSE:HNDA) is one of
the leading manufacturers of automobiles and power products and the
largest manufacture of motorcycles in the world. Honda has always
sought to provide genuine satisfaction to people worldwide. The
result is more than 120 manufacturing facilities in 30 countries
worldwide, producing a wide range of products, including
motorcycles, ATVs, generators, marine engines, lawn and garden
equipment and automobiles that bring the company into contact with
over 19 million customers annually. For more information, please
visit http://world.honda.com.
Source: Honda
Contact:
Honda
Media Inquiries
corporate_pr@hm.honda.co.jp
+81-3-5412-1512
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