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URGENT FIELD SAFETY NOTICE MAGIC DEVICE Systematic:December 1, 2021Commercial Name:MAGIC Device Systematize of Action:Advisory NoticeNuVasive Specialized Orthopedics, Inc (NO) voluntarily issues this
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01
First, gather all the necessary documentation for the product that needs the CE mark suspended for.
02
Identify the specific reason why the CE mark is being suspended and make any required changes to the product or its documentation.
03
Fill out the CE mark suspension form with accurate and detailed information regarding the product and the suspension request.
04
Submit the completed CE mark suspension form to the appropriate regulatory body for review and approval.
05
Await confirmation of the CE mark suspension and ensure that the product is clearly labeled as such during the suspension period.

Who needs ce mark suspended for?

01
Any manufacturer or distributor of a product that has already been certified with a CE mark but requires the mark to be suspended temporarily for reasons such as product recalls, non-compliance issues, or necessary modifications.
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CE mark may be suspended for non-compliance with regulations or safety standards.
Any company placing products on the market that require CE marking may be required to file for CE mark suspension.
To fill out a CE mark suspension, companies must provide details of the non-compliance issue and the actions being taken to address it.
The purpose of CE mark suspension is to ensure that non-compliant products are not placed on the market and pose a risk to consumers.
Companies must report details of the non-compliance issue, actions being taken to address it, and any impact on product safety.
Penalties for late filing of CE mark suspension may include fines and potentially having products removed from the market.
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