Identification and Traceability of Medical Devices
To ensure gapless traceability and thus improve the patient safety of (in-vitro) medical devices, the MDR / IVDR stipulates the Unique Device Identification system. The UDI is a sequence of numeric or alphanumeric characters created using internationally recognized identification and coding standards. It comprises the UDI-DI (Device Identifier) and the UDI-PI (Production Identifier) and is unique for each batch of medical devices produced.
The UDI must be provided in a Human Readable Interpretation (HRI) and an Automatic Identification and Data Capture (AICD) format on the product and package. All UDIs will be registered in the European database on medical devices (EUDAMED) for maximum transparency.
Furthermore, the basic UDI-DI or “regulatory UDI” code for a product group is required for e.g. certificates and correspondence with Notified Bodies, Declaration of Conformity or registration in EUDAMED, but is invisible for the customer or patient.
Kalms Consulting provides support for UDI acquisition including, contact to issuing entities and recommendations for MDR / IVDR compliant labeling of your production and product packaging.
MDR Chapter III, Article 27: Unique Device Identification system
1.The Unique Device Identification system (‘UDI system’) described in Part C of Annex VI shall allow the identification and facilitate the traceability of devices, other than custom-made and investigational devices, and shall consist of the following:
(a) production of a UDI that comprises the following:
(i) a UDI device identifier (‘UDI-DI’) specific to a manufacturer and a device, providing access to the information laid down in Part B of Annex VI;
(ii) a UDI production identifier (‘UDI-PI’) that identifies the unit of device production and if applicable the packaged devices, as specified in Part C of Annex VI;
(b) placing of the UDI on the label of the device or on its packaging;
(c) storage of the UDI by economic operators, health institutions and healthcare professionals, in accordance with the conditions laid down in paragraphs 8 and 9 of this Article respectively;
(d) establishment of an electronic system for Unique Device Identification (‘UDI database’) in accordance with Article 28.