ANSM publishes a regulatory guide for manufacturers of eye prostheses

News Healthcare & Pharma Guidance

Date: 19th May, 2025 Source: French National Agency for the Safety of Medicines and Health Products (ANSM) Country: France Original Source

Brief

"On May 19, 2025, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued an update regarding ANSM publishes a regulatory guide for manufacturers of eye prostheses. The guide addresses the definition and regulatory framework of custom-made medical devices, fabrication requirements, patient information, conformity procedures, and post-market surveillance obligations for eye prostheses in France."

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French National Agency for the Safety of Medicines and Health Products (ANSM)

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ANSM publishes a regulatory guide for manufacturers of eye prostheses

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ANSM publishes a regulatory guide for manufacturers of eye prostheses

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French National Agency for the Safety of Medicines and Health Products (ANSM)

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