What is the impact of the EU UDI regulations on the identification of medical devices sold exclusively in retail?

The GTIN format for medical devices sold in retail should be GTIN-8, GTIN-12 or GTIN-13; but GTIN-14 is not advised as most scanners in retail will not be able to scan them.

Multiple individually wrapped single use products of class I or IIa (e.g. plasters in a sales box) do not require application of UDI-DI either as a bar code nor in human readable format where they are consumer products and the end user is expected to have access to the retail packaging.   

For devices exclusively intended for retail point of sale (i.e. those sold direct to consumers, not via healthcare professionals), the UDI-PIs in AIDC shall not be required to appear on the point of sale packaging.