Video conferencing equipment

Video conferencing equipment used within a healthcare or domestic environment would only fall within the scope of the Medical Devices Directive (MDD) if a medical intended purpose is assigned by its manufacturer via labelling, user instructions or promotional literature. For example, devices which provide diagnostic information and those which are intended to display primary diagnostic information would fall within the scope of the Directive. However, if the system were simply a video conferencing product intended for medical applications we would not consider it to be a medical device, in the same way that a telecommunication system would not be a medical device.

Annex I, Section 13.6 of the Medical Devices Directive (Essential Requirements) requires that the instructions for use supplied with a medical device must include details of the nature and frequency of the maintenance and calibration needed to ensure that devices operate properly and safely at all times. It follows that manufacturers of video conferencing equipment falling within the scope of application of the Directive should make available guidance for routine verification of image quality, including its frequency for diagnostic applications.

This represents our current view on the interpretation of the MDD but cannot be regarded as an authoritative statement of the law nor as having any legal consequences.

For Regulatory Affairs please contact our helpline on 020 7084 3300

For technical assistance:
Richard Glover
Principal Medical Device Specialist
Tel: 020 7084 3245
E-mail: richard.glover@mhra.gsi.gov.uk