Ensure regulatory compliance with expert support in EUDAMED registration, UDI traceability, and effective economic operator management
Medical devices are designed, developed, produced and marketed by the manufacturer. The manufacturer may depend on multiple parties in the logistic chain (Economic Operators) when entering a market, for example:
Manufacturers may further decide to work with distributors to make their devices available further in local markets. Economic operators other than the manufacturer may further perform regulated actions, such as repackaging and relabeling medical devices.
For each of the economic operators, specific regulatory requirements may exist. Such requirements vary from registration in regulatory databases such as EUDAMED for economic operators under MDR or the FDA establishment licence database.
Once registered, parties will need to fulfil regulatory requirements, which may go as far as the need to implement a Quality Management System to ensure activities conform with the regulations, including relevant traceability requirements per the Basic UDI, UDI-DI and the UDI-PI.
In addition, the EU MDR economic operators bear the responsibility to fulfil tasks to ensure that the products they handle conform to the European legislative requirements.
At MedQAIR we have developed a system to support economic operators, for which we refer to our MDIS website.
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