Honda Walking Assist Obtains Medical Device Approval in the EU

Jan 18, 2018 16:25 JST

Source: Honda Motor Co, Ltd

TOKYO, Jan 18, 2018 - (JCN Newswire) - 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.

Honda Walking Assist Device

Honda Walking Assist Device in use

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.

http://www.acnnewswire.com/topimg/Low_HondaHWADevice.jpg
Honda Walking Assist Device

http://www.acnnewswire.com/topimg/Low_HondaHWADeviceUse.jpg
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.

Contact:

Honda
Media Inquiries
corporate_pr@hm.honda.co.jp
+81-3-5412-1512

Source: Honda Motor Co, Ltd
Sectors: Automotive

Related Press Release

Honda Unveils Next-generation EV Series for China

April 17 2024 11:15 JST

Nissan and Honda to start feasibility study of strategic partnership

March 18 2024 11:14 JST

Honda Presents World Premiere of Production Model of "CR-V e:FCEV" at H2 & FC EXPO Tokyo

March 01 2024 20:30 JST

HRC Enters CR ELECTRIC PROTO in International Electric Moto Racing Series

February 02 2024 18:13 JST

Honda to Make Organizational Changes (Effective April 1, 2024) to Further Accelerate the Transformation toward Electrification Business

January 22 2024 18:15 JST

Honda: Ricky Brabec Claims Second Victory at Dakar Rally 2024

January 22 2024 10:10 JST

Honda 2024 Motorsports Program Overview

January 19 2024 13:46 JST

Honda Begins Production of All-new BF350 Large-size Outboard Motor Equipped with V8 350-Horsepower Engine

January 15 2024 08:00 JST

Honda Presents World Premiere of the "Honda 0 Series" Represented by Two New Global EV Concept Models at CES 2024

January 10 2024 12:04 JST

Honda, Tokuyama, and Mitsubishi Corporation to Conduct Joint Demonstration of Decarbonizing Data Center Using By-product Hydrogen and Stationary Fuel Cell Power Station designed to Reuse Fuel Cell Systems from FCEVs

December 25 2023 11:08 JST

More Press release >>

Latest Press Release

First-ever Mazda CX-80 Crossover SUV Unveiled in Europe
Apr 19, 2024 13:50 JST

Fujitsu develops technology to convert corporate digital identity credentials, enabling participation of non-European companies in European data spaces
Apr 19, 2024 10:17 JST

Mitsubishi Heavy Industries and NGK to Jointly Develop Hydrogen Purification System from Ammonia Cracking Gas
Apr 18, 2024 17:01 JST

Toyota Launches All-New Land Cruiser "250" Series in Japan
Apr 18, 2024 13:39 JST

Fujitsu and Oracle collaborate to deliver sovereign cloud and AI capabilities in Japan
Apr 18, 2024 11:14 JST

Eisai: Research on Treatments for Alzheimer's Disease Based on Its Pathological Mechanisms Recieves Award for Science and Technology (Research Category)
Apr 18, 2024 10:53 JST

All-New Triton Confirmed as First Double-Cab Pickup Truck to Achieve 2024 Five-Star ANCAP Safety Rating
Apr 18, 2024 09:22 JST

Eisai's Antiepileptic Drug Fycompa Injection Formulation Launched In Japan
Apr 17, 2024 16:17 JST

Honda Unveils Next-generation EV Series for China
Apr 17, 2024 12:15 JST

Lexus presents Time at the 2024 Milan Design Week
Apr 16, 2024 18:49 JST

Mitsubishi Corporation Announces Participation in a DAC Project in Louisiana, USA
Apr 16, 2024 14:36 JST

New circuit challenge for TOYOTA GAZOO Racing
Apr 15, 2024 17:21 JST

TOYOTA GAZOO Racing back on asphalt for Croatian challenge
Apr 12, 2024 19:36 JST

Heidelberg Materials North America Announces Latest Milestone in Edmonton CCUS Project
Apr 12, 2024 14:39 JST

MHIAEL Completes Expansion of the its Nagasaki Plant for Manufacture of Aero Engine Combustors
Apr 11, 2024 18:08 JST

Mitsubishi Shipbuilding Acquires Approval in Principle (AiP) from Classification Society ClassNK for Ammonia Fuel Supply System (AFSS)
Apr 11, 2024 17:50 JST

DOCOMO, NTT, NEC and Fujitsu Develop Top-level Sub-terahertz 6G Device Capable of Ultra-high-speed 100 Gbps Transmission
Apr 11, 2024 15:10 JST

Mitsubishi Corporation Announces Completion of Capital Raise by Nexamp
Apr 11, 2024 13:07 JST

Mitsubishi Shipbuilding Receives Order for Ammonia Fuel Supply System for Ammonia-Powered Marine Engine
Apr 10, 2024 16:55 JST

Transgene and NEC Present First Clinical Benefits of Neoantigen Cancer Vaccine, TG4050, in Head & Neck Cancer at AACR 2024
Apr 10, 2024 13:36 JST

More Latest Release >>