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Article L5461-5 of the French Public Health Code

Failure by the operator to subject a device mentioned in Article 1 of Regulation (EU) 2017/745 to maintenance obligations and quality controls pursuant to Article L. 5212-1 is punishable by two years’ imprisonment and a fine of €150,000.

Original in French 🇫🇷
Article L5461-5

Le fait, pour l’exploitant de ne pas soumettre un dispositif mentionné à l’article premier du règlement (UE) 2017/745 aux obligations de maintenance et aux contrôles de qualité en application de l’article L. 5212-1, est puni de deux ans d’emprisonnement et de 150 000 € d’amende.

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