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Article R5212-25 of the French Public Health Code

The operator must ensure that the maintenance and quality controls required for the medical devices it operates are carried out. Maintenance is carried out either by the manufacturer or under his responsibility, or by a third-party maintenance supplier, or by the operator himself.

Original in French 🇫🇷
Article R5212-25

L’exploitant veille à la mise en oeuvre de la maintenance et des contrôles de qualité prévus pour les dispositifs médicaux qu’il exploite. La maintenance est réalisée soit par le fabricant ou sous sa responsabilité, soit par un fournisseur de tierce maintenance, soit par l’exploitant lui-même.

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