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2107, 2021

France: ANSM updates guidelines and forms for a scientific opinion for a medical device incorporating a medicinal substance

July 21st, 2021|Compliance, Europe, MDR, Regulatory|2 Comments

The French National Agency for Medicines and Health Products Safety has updated its Guidance and templates for consultation for medical devices with ancillary medicinal substances. Scientific opinion must be requested for any new medical device or device-drug combination product, even if the medical device

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