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Regulation (EU) 2017/746 of the European Parliament and of the CouncilDangos y teitl llawn
Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (Text with EEA relevance)
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3.The UDI
3.1.A UDI shall be assigned to the device itself or its packaging. Higher levels of packaging shall have their own UDI.
3.2.Shipping containers shall be exempted from the requirement in Section 3.1. By way of example, a UDI shall not be required on a logistics unit; where a healthcare provider orders multiple devices using the UDI or model number of individual devices and the manufacturer places those devices in a container for shipping or to protect the individually packaged devices, the container (logistics unit) shall not be subject to UDI requirements.
3.3.The UDI shall contain two parts: a UDI-DI and a UDI-PI.
3.4.The UDI-DI shall be unique at each level of device packaging.
3.5.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.
3.6.Each component that is considered to be a device and is commercially available on its own shall be assigned a separate UDI unless the components are part of a configurable device that is marked with its own UDI.
3.7.Kits shall be assigned and bear their own UDI.
3.8.The manufacturer shall assign the UDI to a device following the relevant coding standard.
3.9.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, any change of one of the following UDI database data elements shall require a new UDI-DI:
(a)
Name or trade name,
(b)
device version or model,
(c)
labelled as single use,
(d)
packaged sterile,
(e)
need for sterilization before use,
(f)
quantity of devices provided in a package,
(g)
critical warnings or contra-indications.
3.10.Manufacturers that repackage or relabel devices with their own label shall retain a record of the original device manufacturer's UDI.
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