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