Real-life monitoring of intra-DRG medical devices using UDI in France

17

Nov 2021

Since October 2021, it is necessary to have the unique device identifier (UDI) of the various models and commercial references of the devices currently on the "intra-DRG" list in order to make it possible to collect and transmit the information relating to the use of these devices in health care establishments.

Certain medical devices are financed within the DRG tariff but require explicit review of clinical evidence by CNEDiMTS to ensure that they are safe and effective. This mechanism is called "intra-DRG (intra-GHS) coverage". The mechanism is applicable to particularly invasive devices. Only devices listed in the intra-DRG list can be purchased by hospitals.

Article L.162-17-1-2 of the Social Security Code provides in particular that the coverage of medical devices registered on the intra-DRG list may be subject to the collection and transmission of information relating to their real-life uses. The use of the unique device identifier (UDI), introduced by European regulation 2017/745 relating to medical devices, makes it possible to ensure this collection and transmission of information by healthcare establishments. That is why since October 2021, it has been necessary to have these UDI codes for all models and commercial references of devices registered in the intra-DRG list. The procedure of collecting UDI codes from manufacturers and distributors is described here.

Except for this, the UDI must now be included in the intra-DRG application file for any new request for registration or modification.

The full details in French can be found here.

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