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title: "EU Declaration of Conformity (Vicon Vero)"
canonical: "https://help.vicon.com/space/regs/12882686/EU%20Declaration%20of%20Conformity%20(Vicon%20Vero)"
format: markdown
---
> Macro (inline-media-image)

 **1912**


    Declaration of Conformity


**Medical Devices Directive 93/42/EEC as amended by **   
** EU Council Directive 2007/47/EC of 5**<sup>**th**</sup>** September 2007**   
** 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  
UNITED KINGDOM

declare that the optical motion cameras as part of a Vero System manufactured by VICON MOTION SYSTEMS LIMITED contribute to meet 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 1(m) Medical device. [Product configurations and software options (Vicon Vero cameras)](https://vicon-help.atlassian.net/wiki/spaces/regs/pages/12881959), 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:**  
EN 60601-1:2006 + 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

![image](media://a351a441-eb01-4b12-81f4-9f365a5cbd8c)

Thomas Shannon, TD PhD FIE (Aust), CPEng (Biomed.)  
Director of Compliance

4<sup>th</sup> May 2021  
**Date Expiration** 17<sup>th</sup> August 2023 (Article 120, EU 2017/745), subject to meeting the continued surveillance obligations, Section 4, Annex V. Certificate Number 20M00097CRT05 8<sup>th</sup> September, 2020.

Not for use in an operating theater, anesthetic gas environment, 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, ionizing radiation, dust ingress, high vibration, 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 electromyography apparatus by clients.