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Identifiers
The UDI is a series of numeric or alphanumeric characters that is created through a globally accepted device identification and coding standard. It allows the unambiguous identification of a specific medical device on the market. The UDI is comprised of the UDI-DI and UDI-PI. The unique identifier may include information on the lot or serial number and be able to be applied anywhere in the world.
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The production of a UDI comprises the following: A UDI device identifier (UDI-DI) specific to a device, providing access to the information laid down in Part B of Annex VI in Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). 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 in Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR). Device identifier (DI) specific information A new UDI-DI shall be required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability. In particular, a new UDI-DI shall be required in the case of any change of the following elements: Name or trade name Device version or model Labelled as single use Packaged sterile Need for sterilisation before use Quantity of devices provided in a package Critical warnings or contra-indications CMR/Endocrine disruptors A UDI-DI shall be associated with one, and only one, Basic UDI-DI. Additional information on this aspect is available at MDCG 2018-1 v3 guidance document. Secondary DI The Secondary DI is an optional field in the DI record, designed to accommodate a DI from an issuing entity other than the Primary DI entity. For example, if your company has previously used GS1 GTIN codes for other purposes but decided to use HIBCC as a Primary DI, you should associate the GS1 GTIN code with the DI record in the Secondary DI field. Production identifier (PI) specific information If a lot number, serial number, software identification or expiry date appears on the label, it shall be part of the UDI-PI. If there is also a manufacturing date on the label, it does not need to be included in the UDI-PI. If there is only a manufacturing date on the label, this shall be used as the UDI-PI. The different types of UDI-PIs include serial number, lot number, software identification and manufacturing date and/or expiry date. The UDI-PI characteristics such as the lot or serial number shall be defined by the manufacturer. However: For active implantable devices, the UDI-PI shall include at least the serial number; for other implantable devices, the serial number or lot number. A configurable device UDI-PI shall be assigned to each individual configurable device. No UDI-PI information can be included in the UDI database. UDI-PI is not included in the regular registration process in EUDAMED (UDI – PI is only registered in the Vigilance module). Basic UDI-DI The Basic UDI-DI is the main access key for device-related information in the EUDAMED database and it is referenced in relevant documentation [e.g. certificates (including certificate of free sale), EU declaration of conformity, technical documentation and summary of safety and (clinical) performance)]. It is intended to identify and connect devices with the same intended purpose, risk class and essential design and manufacturing characteristics. It is independent/separate from the packaging/labelling of the device and it does not appear on any trade item. Any Basic UDI-DI shall identify the devices (group) covered by that Basic UDI-DI in a unique manner. MDCG 2018-1 v3 guidance provides additional information on Basic UDI-DI. The Basic-UDI is the high level grouping for devices with: Same intended purpose Same manufacturer Same attributes Essential characteristics
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