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Article R5211-63 of the French Public Health Code

Where an authorized body finds that the requirements of this Title applicable to this device have not been met or are no longer being met by the manufacturer, or where a certificate should not have been issued, it shall suspend or cancel the certificate issued or place restrictions on it, unless the manufacturer applies appropriate corrective measures to ensure that these requirements are met.

Original in French 🇫🇷
Article R5211-63

Lorsqu’un organisme habilité constate que les exigences du présent titre applicables à ce dispositif n’ont pas été respectées ou ne le sont plus par le fabricant ou lorsqu’un certificat n’aurait pas dû être délivré, il suspend ou annule le certificat délivré ou l’assortit de restrictions, sauf si le fabricant applique, pour que ces exigences soient respectées, des mesures correctives appropriées.

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