+Article 32 9

Article 32 9

9.   Importers shall investigate complaints and follow up on information received on incidents involving an EHR system they made available on the market. Importers shall register those complaints, any recalls or withdrawals of EHR systems and any corrective measure taken to bring the EHR system into conformity, in the register referred to in Article 30(1), point (o), or in their own internal register. Importers shall keep the manufacturer, distributors and, where relevant, authorised representatives informed in a timely manner of the investigation and follow-up carried out and of the results of the investigation and follow-up.

1. Prezentare generală

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Titlu Reglementare

1.1 Referințe

1.2 Cerințe identificate

1.3 Standarde asociate

2. Cerințe identificate

Cerințe
Sursă Cerință

3. Standarde asociate

Standarde
Sursă Cerință