Vicon IX 2000 L Información técnica descargar pdf (Pagina 192)

Regulatory Notices

E-2 Vicon MX Hardware System Reference

MHRA Reporting Adverse Incidents

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 Medical Device Reporting System—Reportable Events on page E-6). The

master Medicines and Healthcare products Regulatory Agency (MHRA) file is

located at Vicon Motion Systems Limited. Should an adverse event occur, the

following 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 are acceptably safe. Use the

form in this appendix to report an adverse incident involving a medical

device. Full information and guidance on reporting Adverse Incidents

is published in MHRA Device Bulletin DB2006(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

Tel: +44 (0)20 7084 2000

Fax: +44 (0)20 7084 2353

Web: www.mhra.gov.uk

Tip

You can obtain and complete an online version of the MHRA Adverse Incident

Report Form from the MHRA Web site (www.mhra.gov.uk).

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Vicon IX 2000 L Información técnica Pagina 192