French Notified Body Initiates Product Recall for Breast Implants

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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Michael Gerrits

Michael Gerrits

Michael Gerrits is attorney at “Van Diepen Van Der Kroef Advocaten” in Amsterdam. He is specialized in product safety regulations and intellectual property rights. Michael helps companies to implement product regulations into their business processes. He is also a well sought after speaker at conferences and events. Also read Michael’s profile at LinkedIn.