In line with Article 27 of the (EU) 2017/745 Medical Device Regulation (MDR), manufacturers for all medical devices, except for custom-made devices to be certified under MDR;
- a) the creation of a UDI, including:
1) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device
2) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices
- b) placing of the UDI on the label of the device or on its packaging and before a device is placed on the market the manufacturer shall ensure that the information referred to in Part B of Annex VI of the device in question are correctly submitted and transferred to the UDI database referred to in Article 28.
- UDI carriers are placed on the label of the device and on all upper levels of the packaging. Upper levels of packaging do not include shipping containers.
- The UDI shall be used for reporting serious incidents and field safety corrective actions in accordance with Article 87
- The Basic UDI-DI, as defined in Part C of Annex VI, of the device shall appear on the EU declaration of conformity referred to in Article 19.
- Manufacturers shall keep the list of all assigned UDIs up to date as part of the technical documentation referred to in Annex II.
The guidance document “MDCG 2021-25” has been published for legacy devices manufactured within the scope of the Medical Device Regulation (93/42/EEC) and to be placed on the market after 26.05.2021.
According to this guide, it is seen that MDR “Article 27 Single Device Identification System” is not applicable for legacy devices, while “MDR Article 29 Devices Registration” provision is applicable.
In this context, the guidance document published on “Registration of Legacy Devices in MDCG 2019-5 EUDAMED” provides information on how to EUDAMED registration of legacy devices that do not have Basic UDI-DI according to MDR article 27.
In line with the MDR and guidance documents, there is no obligation to have UDI on the legacy devices themselves, on their labels and on their packaging.