According to MDR Article 25, distributors and importers shall cooperate with manufacturers or Authorised Representatives to achieve an appropriate level of traceability of devices.
Economic operators shall be able to identify the following to the competent authority:
- any economic operator to whom they have directly supplied a device;
- any economic operator who has provided them directly with a device;
- any health institution or healthcare professional to which they have provided a device directly.
BioReg can help you map complex supply chain interrelationships and efficiently define the obligations and responsibilities of each supply chain subject.
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