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Supplier Quality Agreement Mdr

Manufacturers must now have at their disposal someone in their organization who has specific responsibility for compliance with device legislation. Even micro-organizations and small organizations must have such a person „permanently and continuously.“ For these small organizations, the PRRC must be mentioned as a critical supplier in the manufacturers` quality systems and a specific written agreement must be concluded between the two parties. The activity in the previous section allows for proactive planning for the assessment and audit planning of the notified body. The advanced organization or process graph allows an objective view of the links between your organization and your suppliers. The detailed links between your organisation and your suppliers have shown the notified body that you have implemented a system-wide assessment of your outsourced processes. By implementing controls that match the risks presented in the organ or process diagram, you provide a clear summary of the appropriate supplier controls. Granting a supplier authorisation for a simple assessment and consultation of suppliers is not sufficient preparation for the examination to which a critical supplier may be subjected by your notified body. Conversely, it should be clarified, in the context of the relevant agreement, that the PRRC has the right to raise any concerns it has with regard to any of the above-mentioned problems, without prejudice to its employment status or appointment. In the context of the MDR, it has become essential to ensure smooth and transparent cooperation between all economic actors in the medical device supply chain. This proposal therefore proposes the contractual clauses to be included in the quality agreement between the distributor/importer and the manufacturer.

establish, maintain and continuously improve a quality management system (QMS) at the production site (or require the contract manufacturer to comply with the legal manufacturer`s QMS system, obliging the contract manufacturer to comply with updates provided to it by the legal manufacturer); 4: Notified bodies are required to maintain unannounced audit procedures, including those of subcontractors and suppliers. On the basis of the above, it will obviously be important, when selecting medical device distributors, to ensure that they have the necessary capacity to perform these new regulatory functions. As regards the documentation of contracts, it will no longer be sufficient to provide in general terms that the manufacturer assumes responsibility for all quality assurance and regulatory measures in the territory concerned. For clarity, roles and responsibilities should be detailed. Where the distributor is reasonably to consider that there is a serious risk and intends to apply to the competent authority, the manufacturer and other economic operators should be informed accordingly in order to ensure that corrective action can be taken without delay. . . .

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