MDR - annex VI - PArt B - article 2

Original text

Expert opinion

2. the Basic UDI-DI as referred to in Article 29 and any additional UDI-DIs

Core data which are to be provided to the EUDAMED before marketing a product, include the UDI-DI.

In addition, the UDI-DI shall be provided beforehand in cases of a conformity assessement by authorities.

The UDI-DI applies to medical devices, procedure packs and kits.

Exempt from this are custom-made devices.


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