Article L5461-9 of the French Public Health Code
November 6, 2023
The following constitutes a breach subject to a financial penalty: 1° The fact, for the manufacturer of a device mentioned in Article 1 of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 or, where applicable, for its authorised representative, having become aware of a serious incident occurring on French territory concerning this device, of failing to notify it to the National Agency for…
