Basic principles of cooperation with regard to the communication of events relevant to monitoring and information after the placing on the market of products for compliance with the Medical Devices Directive 93/42/EEC and the EU Medical Devices Regulation 2017/745 (MDR).
In accordance with the aforementioned regulations for medical devices, the acquisition, maintenance and distribution of products are the activities of the distributors; also referred to here as specialist dealers.
Distributor: Any natural or legal person in the supply chain other than the manufacturer or importer who makes a product available on the market until it is put into service.
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
The dealer/distributor shall inform servoprax GmbH in writing of all complaints he has received about the products of servoprax GmbH and shall observe a period of two (2) business days from receipt of these complaints.
If the dealer/distributor is of the opinion or has reason to believe that a product that he has placed on the market is not in conformity with the requirements of the valid regulation, he must immediately inform servoprax GmbH thereof.
If the dealer/distributor receives complaints or reports from end users (medical specialists, patients or users) about suspected incidents in connection with a product that he has provided, he must immediately forward this information to servoprax GmbH.
The dealer/distributor shall keep records of complaints, non-compliant products, recalls and returns, inform servoprax GmbH of these activities and provide all relevant information upon request.
In the event of a complaint, the specialist dealer/distributor shall cooperate with servoprax GmbH and assume responsibility for coordinating all measures in the area so that the investigations requested by servoprax GmbH or the manufacturer can be carried out.
servoprax GmbH or the manufacturer, as the case may be, is responsible for investigating complaints and for the reporting procedure to the competent authority within the area.
If the investigation by servoprax GmbH or, if applicable, the manufacturer reveals that a recall of the product is necessary, the dealer/distributor agrees to comprehensive cooperation with servoprax GmbH or, if applicable, with the manufacturer and his authorised representative so that the recall can be carried out thoroughly and efficiently.
The dealer/distributor undertakes to return all recalled products to servoprax GmbH within five (5) working days of completion of the recall.
The dealer/distributor shall cooperate with servoprax GmbH, the manufacturer, the authorized representative of the manufacturer, the importer and the responsible authorities, if applicable, in order to carry out the necessary corrective measures, which are required in each case for the manufacture of conformity, for the withdrawal or recall of the product.
The dealer/distributor shall, on request, cooperate with the competent authorities on any action taken to eliminate the risks posed by products placed on the market by the dealer/distributor.
If the competent authority contacts the dealer/distributor directly in connection with complaints, the dealer/distributor agrees to inform servoprax GmbH comprehensively of the details of these discussions or consultations.