New in Vicon Nexus 2 - Regulatory notices

Regulatory notices

This topic provides required regulatory notices and incident report forms relating to the supply and use of Vicon systems in the United Kingdom and in the United States of America.

Medical device adverse event reporting

Use the appropriate information and form to report any adverse events involving Vicon systems:

❙ MHRA Adverse Incident Reporting (UK)

❙ FDA MedWatch Adverse Event Reporting Program (US)

Should an adverse event occur, complete the appropriate form and forward it within one working day to Vicon Motion Systems Limited at one of the following addresses:

Denver, CO	Los Angeles, CA
Vicon Denver 7388 S. Revere Parkway Suite 901 Centennial CO 80112 USA T:303.799.8686 F:303.799.8690 E: [email protected]	Vicon LA 5419 McConnell Avenue Los Angeles CA 90066 USA T:310.306.6131 F:310.437.4229 E: [email protected]
Oxford, UK	Singapore
Vicon Oxford 14 Minns Business Park West Way Oxford OX2 0JB UK T:+44.1865.261800 F:+44.1865.240527 E: [email protected]	Vicon Singapore 8 Cross Street # 11-00 PWC Building Singapore 048424 T:+65 6400 3500 E: [email protected]

MHRA Adverse Incident Reporting (UK)

The information in this section covers the reporting of incidents involving medical devices to the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Tip: Notice to Agents:
For inclusion in all Vicon systems supplied from the United Kingdom for use outside of the United States of America (for supply and use in the US, see FDA MedWatch Adverse Event Reporting Program).

The master Medicines and Healthcare products Regulatory Agency (MHRA) file is located at Vicon Motion Systems Limited. Should an adverse event occur, the MHRA Adverse Incident Report Form is to be completed and forwarded within one working day to Vicon Motion Systems Limited.

The Medicines and Healthcare products Regulatory Agency (MHRA) is a UK government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. Use the form referenced below to report an adverse incident involving a medical device.

Full information and guidance on reporting Adverse Incidents is published in MHRA Device Bulletin DB 2008(01) Reporting Adverse Incidents and Disseminating Medical Advice Alerts. For details on reporting requirements, contact the MHRA:

Medicines and Healthcare products Regulatory Agency
Market Towers 1 Nine Elms Lane
London SW8 5NQ
UK

Tel: +44 20.7084.2000
Fax: +44 20.7084.2353
web: www.mhra.gov.uk.

MHRA Adverse Incident Report Form

You can obtain the MHRA Adverse Incident Report Form from the MHRA web site (www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/Medicaldeviceadverseincidentreportingforms/index.htm). Separate online and printed versions of the form are available on that web site.

Important: If you have any difficulty obtaining the MHRA Adverse Incident Report Form, contact Vicon Support.

To complete the MHRA Adverse Incident Report Form:

1. Go to www.mhra.gov.uk/Safetyinformation/Reportingsafetyproblems/Devices/Medicaldeviceadverseincidentreportingforms/index.htm).

2. Print and complete the form in your required format. Then:

– Send it to [email protected], including Adverse Event Report in your email subject line.

– Fax it to the nearest Vicon office (for contact details, see Regulatory notices).

Tip: In the section Type of device, select Other and specify your Vicon system.

FDA MedWatch Adverse Event Reporting Program (US)

This section covers the reporting of incidents to the US Department of Health & Human Services.

Tip: Notice to agents:
For inclusion in all Vicon systems supplied to the United States of America (for supply and use outside the US, see MHRA Adverse Incident Reporting).

The master Medical Device Reporting (MDR) file is located at Vicon Motion Systems Limited. Should an adverse event occur, MEDWATCH Form FDA 3500A (10/05) is to be completed and forwarded within one working day to Vicon Motion Systems Limited.

Department of Health & Human Services,
US Food and Drug Administration
Medical Device Reporting System—Reportable Events

Code of Federal Regulations
Title 21, Volume 8
Revised as of April 1, 2006
Cite: 21CFG803.32

Under 803.1(a) device user facilities and manufacturers must report deaths and serious injuries that a device has or may have caused or contributed to. Should such an event occur, please complete the form specified in this section and forward it in accordance with the applicable regulations and time limits to your nearest Vicon office (for addresses, see Regulatory notices).

FDA Adverse Event Report Form

You can obtain the FDA Adverse Event Report Form (MEDWATCH form FDA 3500A) from the FDA's MedWatch Adverse Event Reporting program on their web site (www.accessdata.fda.gov/scripts/medwatch/). This PDF form can be completed online or printed out.

Important: If you have any difficulty obtaining the FDA Adverse Event Report Form, contact Vicon Support.

To complete the Adverse Event Report form (MEDWATCH form FDA 3500A):

1. Go to www.accessdata.fda.gov/scripts/medwatch/.

2. Print and complete the PDF form. Then:

– Send it to [email protected], including Adverse Event Report in your email subject line;

– Fax it to the nearest Vicon office (for contact details, see Regulatory notices).

Tip: Section C. Suspect Product(s) is not applicable to Vicon systems. For further guidance on completing the form, see the instructions contained in the PDF form.