MDR - Chapter III - article 25

Original text

Expert opinion

Identification within the supply chain

1. Distributors and importers shall co-operate with manufacturers or authorised representatives to achieve an appropriate level of traceability of devices.

Supply chain traceability

Within the meaning of the traceability of the products supplied to the market, all economic operators shall cooperated with the legal manufacturer or the EC REP, whichever applies. The traceability includes any PMS efforts.

2. Economic operators shall be able to identify the following to the competent authority, for the period referred to in Article 10(8):

(a) any economic operator to whom they have directly supplied a device;

(b) any economic operator who has directly supplied them with a device;

(c) any health institution or healthcare professional to which they have directly supplied a device.

For a period of 10 years after the last product being supplied to the market, and 15 years for implantable devices, the traceability must be available. The traceability should be in such a way as to be able (as any of the economic operators, i.e. importer, distributor, EC REP or legal manufacturer) to demonstrate to the competent authorities, that:

a) and b) the chain of custody per starting from each economic operator to the next of kin

c) any Health Care Professional (HCP) is known to which a product has been supplied.

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