2017/745_AnnexI  _ II_III_ IV_ V_ VI_ VII_ VIII_IX_X_XI_XII_XIII_XIV_XV_XVI_XVII

CHAPTER III

IDENTIFICATION AND TRACEABILITY OF DEVICES, REGISTRATION OF DEVICES AND OF ECONOMIC OPERATORS, SUMMARY OF SAFETY AND CLINICAL PERFORMANCE, EUROPEAN DATABASE ON MEDICAL DEVICES

Article 25
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.
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.

Article 26
Medical devices nomenclature


To facilitate the functioning of the European database on medical devices (‘Eudamed’) as referred to in Article 33, the Commission shall ensure that an internationally recognised medical devices nomenclature is available free of charge to manufacturers and other natural or legal persons required by this Regulation to use that nomenclature. The Commission shall also endeavour to ensure that that nomenclature is available to other stakeholders free of charge, where reasonably practicable.