Vigilanz

Basic principles of cooperation with regard to the notification of post-market surveillance events and information for compliance with the Medical Devices Directive 93/42/EEC and the EU Medical Devices Regulation 2017/745 (MDR).

In accordance with the said Medical Devices Regulations, the acquisition, maintenance and distribution of devices are part of the Distributors' scope of activities.

Distributor: Any natural or legal person in the supply chain, other than the manufacturer or importer, who makes aproduct available on the market until it is put into use.

Incident: Any malfunction or defect in the characteristics or performance of a product after it has been placed on the market. This includes user errors due to ergonomic features, insufficient information from the manufacturer and any undesirable side effects.

Reporting procedures for complaints and incidents

If the Distributor believes or has reason to believe that a product it has placed on the market is not compliant with the requirements of the applicable regulation, it must immediately notify Diaprax GmbH.

If the Distributor receives complaints or reports from end users (healthcare professionals, patients or users) about suspected incidents related to a product that it has provided, it must forward this information immediately to Diaprax GmbH.

The distributor shall keep records of complaints, non-conforming products, recalls and returns, inform Diaprax GmbH of these activities and provide all related information upon request.

In the event of a complaint, the Distributor shall cooperate with Diaprax GmbH and shall assume responsibility for coordinating all actions in the territory so that the investigations requested by Diaprax GmbH or the manufacturer can be carried out.

Diaprax GmbH, or the manufacturer if applicable, is responsible for the investigation of complaints and for the reporting procedure to the competent authority within the area.

If the investigation by Diaprax GmbH, or the manufacturer if applicable, determines that a recall of the product is necessary, the Distributor agrees to cooperate fully with Diaprax GmbH, or the manufacturer if applicable, and its authorized representative so that the recall can be conducted thoroughly and efficiently.

The Distributor agrees to return all recalled products to Diaprax GmbH within five (5) business days of the completion of the recall.

The Distributor shall cooperate with the manufacturer and its authorized representative, if any, so that the recall can be conducted thoroughly and efficiently.

The Distributor shall cooperate with Diaprax GmbH, the manufacturer, the manufacturer's authorized representative, the importer, and the appropriate authorities, as applicable, to take the corrective actions necessary to bring the product into compliance, recall, or withdrawal.

The distributor shall cooperate with the competent authorities, upon request, on any action taken to eliminate the risks posed by the products that it places on the market.

The Distributor shall notify Diaprax GmbH in writing of any complaints it has received about Diaprax GmbH's products, allowing a period of two (2) business days from receipt of such complaints.

If the competent authority contacts the Distributor directly in connection with complaints, the Distributor agrees to keep Diaprax GmbH fully informed of the details of such discussions or consultations.