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It is clear from the above that, in the selection of medical device distributors, it will obviously be important to ensure that they have the capacity to perform these new regulatory functions. With regard to the documentation relating to contractual relations, it is no longer sufficient to provide in general that the manufacturer assumes responsibility for all quality assurance and regulatory transactions in the territory concerned. Roles and responsibilities should be detailed for clarity. In the event that the distributor reasonably believes that there is a serious risk and intends to go to the appropriate authority, the distributor should be required to inform the manufacturer and other economic operators to ensure that corrective action can be taken without delay. The redundancy, renewal and liability provisions should be adapted to reflect new regulatory functions and reporting obligations should be reissued if such a key function is not satisfactorily met. The agreements should define all the conditions that should be grounds for termination in the event of an infringement. Rather than relying on the supplier`s risk management in its processes, you should be part of a risk management package that specifically deals with the process, as it affects the compliance of your finished device. In other words, don`t rely exclusively on a generic process error mode and an effect analysis (pFMEA) provided by your provider. Your supplier is in the best position to understand potential problems in the process. However, you are better able to determine the risks of these problems to your finished device.
Continuously update and improve a quality management system (« QMS ») at the production site (or provide the contract manufacturer with an obligation to comply with updates notified by the legal manufacturer); Accordingly, the PRRC should be hired through an employment contract or consulting contract that must expressly confirm their obligations. It should also ensure that aircraft compliance is verified in accordance with the QMS, the development and updating of technical documentation, and the recording of control measures and serious incidents on site. In the event that these obligations are not met satisfactorily despite performance controls, the manufacturer should have the right to terminate the contract and ensure that a new PRRC can be appointed as soon as possible, as this will of course be a critical function for organizations. 1: Supplier selection and control are recognized in the MDR as part of resource management; Therefore, resource management activities should also include suppliers. 4: Notified bodies are required to maintain unannounced review procedures, including the procedures of subcontractors and suppliers. 5: The MDR describes the specific QMS subsystems that a notified organization must review, including purchase controls and verification of purchased equipment. This requirement overlaps with the supplier`s control requirements and must be taken into account when planning your compliance approach. Speaking of delivery risks, setting up alternative suppliers at that time can prevent a delay in a critical component or service.