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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:

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 is to be completed and forwarded within one working day to Vicon Motion Systems Limited.

Full information and guidance on reporting Adverse Incidents is available on the MHRA Yellow Card website. For details on reporting requirements, contact the MHRA:

Medicines and Healthcare products Regulatory Agency
151 Buckingham Palace Road
Victoria, London SW1W 9SZ
UK

Tel: +44 (0)20 3080 6000
Fax: +44 (0)20 3118 9803
Web: www.mhra.gov.uk

Tip:          For additional information and guidance, refer to the latest revision of MEDDEV 2.12-1 on The European Commission Web site
 (http://ec.europa.eu/health/medical-devices/files/meddev/2_12_1_ol_en.pdf).

MHRA Adverse Incident Report Form

You report adverse incidents on the MHRA web site (https://yellowcard.mhra.gov.uk/https://yellowcard.mhra.gov.uk/). You can either report the problem online or use a printed version of the MHRA Adverse Incident Report, which is also available from that web site.

Important:   If you have any difficulty obtaining the MHRA Adverse Incident Report, contact Vicon Support immediately to receive the form.

To complete the MHRA Adverse Incident Report Form:

1.    On the MHRA web site (https://yellowcard.mhra.gov.uk/https://yellowcard.mhra.gov.uk/), click the Devices button.

2.    Complete the subsequent parts of the form, including an email address to which your own printer-friendly version of the report can be sent. Remember to complete the Email copy of report to field with Vicon’s email address.

3.    Finish completing all sections of the report (you must complete all entries flagged with a red asterisk) and submit the form online.

4.    If you want to work with a printed copy, retrieve the printer-friendly copy from your email. If required, you can print and fax the form to the nearest Vicon office (see ).

Tip:          In section Type of device, select General Report Form / All other devices and on the next page, in the Type of device field, specify your Vicon system and device.

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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 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, 2014
Cite: 21CFG803.50

Under 803.50(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/). The form can be completed online or printed out.

Important:   To download a PDF of the form, click the Download Forms link at the bottom of the page. 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.    Either complete the online MedWatch Voluntary Report or print and complete the PDF form. Then:

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

or

–           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.

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