什么是UKCA？

上海角宿Mia

UKCA，是UK Conformity Assessed简称。UKCA标识是一种新的英国产品标识。2019年2月2日，英国政府公布了在无协议脱欧的情况下将会采用UKCA标识方案。
UKCA标识和CE标识一样，都是由制造商负责确保产品符合法令规定的标准，并按照规定程序进行自我声明后，在产品上做相应的标识。
而后来，英国政府由于疫情的原因，将CE标志的截止使用期限从2022年1月1日延长到2023年1月1日。在此之后，只有加贴UKCA标志的产品才被英国市场所接受。
现在，针对CE标识过渡到UKCA标识几个阶段列明如下：
2020年12月31日之前已经生产好并投放市场的产品，仍可继续使用已有的CE标识在英国市场销售。
2021年1月1日之后投放的产品，英国进口商需确保进入英国市场的产品，具备符合性评估技术文档和制造商符合性声明DOC ，产品上有标识英国进口商的公司名称地址和联系信息，同时进口商需持有并保存制造商DOC 10年。

明月清风7706

谢谢楼主，学习了！

猪才怪

We are writing to provide an update to the implementation of the
future medical device regulations.



In October 2022, the MHRA announced an intention to introduce a
12-month extension to the implementation of the future medical device
regulations. This included the continued acceptance of CE marked devices until
30 June 2024, followed by subsequent transitional arrangements as outlined in
the the government response to the
consultation.



Currently, CE marked medical devices with a valid CE mark can be
placed on the Great Britain (GB) market until 30 June 2023.



We now intend to introduce measures that will extend acceptance of
CE marked medical devices in GB beyond 30 June 2023. As detailed further below,
it will put in place transitional arrangements for defined periods for
accepting CE marked medical devices in GB (depending on the type of device and
the EU legislation it complies with). This is primarily to smooth the
transition to a future regime and help ensure continued supply of medical
devices to the GB market. We are aiming for core aspects of the future regime for
medical devices to fully apply from 1 July 2025. In setting this timeline we
have taken on board feedback from external stakeholders, including concerns
about limited capacity of conformity assessment bodies.



More specifically, we have laid legislation that will, subject to
Parliamentary approval, provide that CE marked medical devices may be placed on
the Great Britain market to the following timelines:



general medical
     devices compliant with the EU medical devices directive (EU MDD) or EU
     active implantable medical devices directive (EU AIMDD) with a valid
     declaration and CE marking can be placed on the Great Britain market up
     until the sooner of expiry of certificate or 30 June 2028
in
     vitro diagnostic medical devices (IVDs) compliant with the
     EU in vitro diagnostic medical devices directive (EU IVDD) can be placed
     on the Great Britain market up until the sooner of expiry of certificate
     or 30 June 2030,
     and
general medical
     devices, including custom-made devices, compliant with the EU medical
     devices regulation (EU MDR) and IVDs compliant with the EU in vitro diagnostic
     medical devices regulation (EU IVDR) can be placed on the Great Britain
     market up until 30
     June 2030.



This would enable certain CE marked medical devices to continue to
be placed on the Great Britain market for longer. The above timelines will not
include class I medical devices and general IVDs under the Directives where the
conformity assessment under the relevant Directive and under the EU MDR or EU
IVDR does not involve a notified body. Similarly, they will not include
custom-made devices that are compliant with the EU MDD or EU AIMDD.



Please note that these proposals are subject to parliamentary
agreement and may change. We will continue to update you of any changes.



Also, we communicated in March 2023 that the EU has taken steps to give
manufacturers more time to get certain medical devices certified under the EU
Medical Devices Regulation (EU MDR), including extending validity of
certain CE certificates. To provide greater clarity for industry, we have
published guidance about
acceptance of such certificates on the Great Britain market.



For further information, please see the latest update on the implementation of the future
regulations for medical devices.



Thank you,


The Medicines and Healthcare products Regulatory
Agency