1912Declaration of Conformity
Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5th September 2007
We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
declare that VICON NEXUS Software utilized within the Vantage or Vero Gait Analysis Systems and manufactured by VICON MOTION SYSTEMS LIMITED meets ANNEX V of the Medical Devices Directive 93/42/EEC in that the Quality Management System has been approved by Dare!! Services B.V., a notified body of the European Union (Reg No. 1912) for the manufacture and support of the aforementioned CLASS 1(m) medical device.
declare that the medical devices listed below and bearing the CE marking, conform with the essential requirements of the Directive 93/42/EEC as amended by Directive 2007/47/EEC. Applicable harmonized standards have been used to demonstrate the safety and efficacy of the device when used in accordance to the Software Instructions for Use. The following standards were applied:
EN ISO 9001:2015
EN ISO 13485:2016
EN ISO 14971:2012
BS EN 62304:2006 + A1:2015, IEC 62304:2006/A1:2015
NEXUS Data capture software for clinical gait, biomechanics, and sports sciences. Incorporates implementation of independently validated biomechanical Models. CLASS I(m).
Polygon Tool for reporting and presentation, enabling communication and sharing of data. Legacy Supported CLASS I.
Each version of software is released in accordance with records certifying compliance with the specifications.
This declaration of conformity is issued under the sole responsibility of the manufacturer.
Thomas Shannon TD PhD FIE (Aust) CPEng (Biomed.)
Director of Compliance
The Declaration is valid from 4th May 2021
Date of Expiration 17th August 2023 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V. Certificate Number 20M00097CRT05 8th September, 2020.
