1912Declaration of Conformity
Medical Devices Directive 93/42/EEC as amended by
EU Council Directive 2007/47/EC of 5th September 2007
Article 120 Medical Devices Regulation EU 2017/745 and
Electromagnetic Compatibility to EMC Directive 2014/30/EU
Electrical Safety to Low Voltage Directive 2014/35/EU
We, Vicon Motion Systems Limited
Unit 6, Oxford Industrial Park
Mead Road, Yarnton, Oxford, OX5 1QU
declare that the VICON Active Wand manufactured by VICON MOTION SYSTEMS LIMITED meets ANNEX V and VII, Section 5 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 I (m) Medical device. Product configurations and software options (Active Wand) detail the product configurations and software options that conform to the metrological requirements of the Directive.
This declaration of conformity is issued under the sole responsibility of the manufacturer.
VICON MOTION SYSTEMS LIMITED has tested and demonstrated that all products of its own manufacture meet 2014/30/EU:
Electromagnetic Compatibility to:
EN60601-1-2:2007
General Requirements for Safety to:
Active Wand EN60601-1:2006 + A12:2014
Software Development, Conformity and Support
EN ISO 13485:2016
EN ISO 14971:2019
BS EN 62304:2006 + A1:2015, IEC 62304:2006/A1:2015
Thomas Shannon TD PhD FIE (Aust) CPEng (Biomed.)
Director of Compliance
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.
Not for use in an operating theatre anaesthetic gas or oxygen-rich environments. Not for use where there is a risk of compromising the essential performance of medical electrical equipment. Not suitable for use in high magnetic flux, ionising radiation, sterile, or life- or safety-critical environments.
Note: The overall installed system classification is defined by the highest risk device connected, which may include the connection of approved third-party equipment, such as electro-myography apparatus, by clients.
