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MEDLEY 2 121 rev. 8 Vigilance EUROPEAN COMMISSION DG Health and Consumers (SANCHO) Directorate Consumer Affairs Unit B2 Health Technology and Cosmetics MEDICAL DEVICES: Guidance document MEDLEY 2.121
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What is vigilance revision 8?
Vigilance revision 8 is an update of the surveillance process in an organization.
Who is required to file vigilance revision 8?
All employees and stakeholders involved in the vigilance process are required to file vigilance revision 8.
How to fill out vigilance revision 8?
Vigilance revision 8 can be filled out electronically or manually, following the instructions provided by the organization.
What is the purpose of vigilance revision 8?
The purpose of vigilance revision 8 is to ensure that the surveillance process is up to date and compliant with regulations.
What information must be reported on vigilance revision 8?
Information such as incidents, investigations, and corrective actions must be reported on vigilance revision 8.
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