French Notified Body Initiates Product Recall for Breast Implants

The French Notified Body ANSM (The National Security Agency of Medicines and Health Products) recommended breast implants produced by Cereplas to be recalled from the European market.

The ANSM informs that there are administrative flaws in the sterilization procedure. While there is no health issue with the actual implants, the sterilization procedure does not comply with the European standards. Following the EU legislation, the procedure should be re-assessed every two years. And the French manufacturer Cereplas has not performed the necessary sterilization procedure assessment on time.

Consequently, the Notified Body has declared that until the issue is solved, the breast implants marketed by Cereplas are non-compliant with the CE requirements. Thus, all products will be pulled out of the European market.

As long as the CE Declaration of Conformity is not valid, the manufacturer is not allowed to market the products on the EU market.

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5 thoughts on “French Notified Body Initiates Product Recall for Breast Implants”

  1. My organization is having a variety of products manufactured, most of which are elegible for self certification by the various manufacturers. We had hoped to opt for 3rd party certification and marking to avoid obvious liability implications. However, we have been informed by a Notified Body that if the self certification requirement applies, then that is mandatory, not an option.
    Has anyone experienced this previously?

    • AK. It does not mean that you cannot involve a 3rd party in the process. BTW, you write that you would like to involve a 3rd party for the liability implications. However, you should note that under the CE legislation a manufacturer always is responsible and liable, whether a Notified Body was involved or not.

  2. Han,
    Thank you for taking the time to reply. When you say that the 3rd party can be involved, does that mean the 3rd party can certify and apply the marking? Also, I appreciate your clarification regarding the liability issue.

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