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Suggested Change to QSP 9.1-5, Advisory Notice, Recalls, and Vigilance Reporting

(Published November 2009)

We wanted to let you know that the European Commission website has been redesigned and an important web page listing Vigilance Contact Points within Competent Authorities has moved.

Many manufacturers reference this list of Competent Authority vigilance contacts in their regulatory documents, but the link to that document no longer functions.

Previous Link (does not function):
http:// ec.europa.eu/enterprise/medical_devices/ca/ca_vig.htm

NEW Link:
http://ec.europa.eu/enterprise/sectors/medical-devices/files/list-of-vigilance-contact-points-within-the-national_en.pdf

Specifically, if you have a QSP 9.1-5, Advisory Notice, Recalls, and Vigilance Reporting, Section 6.9.7, you will need to update it with the new link above.

Currently, you will not find a link to this PDF document from the “Market Surveillance and Vigilance” page, but it can be located on the left-hand sidebar of the redesigned website, under the drop down menu entitled “Useful Links.” Here you will see a section entitled “National Competent Authorities” with a link to the “Vigilance Contact Points” PDF document.

Should you have any questions, please do not hesitate to contact us.

Kind regards,