Using the UK Conformity Assessed (UKCA) Mark After Brexit

你准备好使用UKCA Brexit后马克吗?一个re your EMC, Low Voltage, Radio Equipment, or ATEX products compliant with this? A conformity mark must be used when placing certain products on the UK market.

Before 1 January 2021, you can do this using the CE mark or other appropriate marks. From 1 January 2021, the UKCA (UK Conformity Assessed) mark will be the conformity assessment marking for Great Britain for most goods currently subject to CE marking.

什么是UKCA标志，它将使用它在哪里？

The UKCA marking is a new UK product mark used for goods placed on Great Britain's market (England, Wales, and Scotland). The marking covers most products that previously required CE marking. It will not be used for products placed on the Northern Ireland market, which require CE marking or UK(NI) marking. Products currently requiring a CE marking for sale in the EU will continue to need a CE mark.

从2021年1月1日起需要做的事情取决于产品的类型。新的UKCA规则对于目前在EMC，低压，无线电设备或ATEX指令下认证的产品清楚。有不同的规则：

• 在旧方法下监管的产品，特别是：化学品，药品，车辆和航空航天
• Products covered by national regulations (non-harmonized)
• 某些其他产品，如医疗设备，民用炸药，施工产品和铁路互操作性

The UKCA regulatory regime will apply regardless of any Free Trade Agreement (FTA) between the UK and EU. Although the UK is seeking a Mutual Recognition Agreement for conformity assessment in the UK-EU FTA, this is currently refused by the EU. Companies whose products require mandatory third-party testing by a Notified Body should review whether that Body is located in the UK or EU and whether it has arranged to have certification validated or re-issued by a partner test body in the other market.

When will it be introduced?

The UKCA marking can be used from 1 January 2021. While the UKCA marking has no legal meaning if placed on any product before this date, you are encouraged to be ready to use it in advance.

对于需要时间调整新要求的企业，将在2022年1月1日之前进行过渡期，在此期间，您将能够继续使用英国的CE标志。欧盟没有互惠过渡。

从2021年1月1日,如果你应用UKCA marking, you must meet all of the UKCA regulations' requirements.

一个fter 1 January 2021, you must use the new UKCA marking immediately if all of the following apply:

• The product is covered by legislation that requires the UKCA marking
• The product requires mandatory third-party conformity assessment
• 一个conformity assessment has been carried out by a UK based Notified Body and you haven’t transferred your conformity assessment files from your UK body to an EU-27 recognized Notified Body before 1 January 2021

这不适用于预先存在的库存库存，这些库存已在2020年12月31日之前已经标记的完全制造和符合性。这笔股票仍然可以在2021年1月1日之后的GB市场上，现有标记和通知的身体数字。

Up until 1 January 2022, under the transition arrangements, you will be able to continue to use the CE marking in the United Kingdom if:

• You currently apply the CE marking to your product on the basis of self-declaration
• 一个mandatory third-party conformity assessment was carried out by an EU-27 recognized Notified Body
• The EU-Type Examination certificate previously held by a UK Notified Body has been transferred to an EU-27 recognized Notified Body

重要的是要注意，您只能将CE标记的商品放在英国，而英国和欧盟要求保持不变。如果欧盟改变其规则和您的货物根据这些新的欧盟规则，您将无法再使用英国的CE标记。

在2022年1月1日之后，Ukca标记将取代英国的所有CE标志。

一个fter 1 January 2021, you may choose to use the UKCA marking after Brexit, even if the transition arrangements would apply, for example, where your customer insists on the new mark.

There is no transition arrangement for products certified by UK Notified Bodies. To continue to be sold in the EU-27 after 1 January 2021, the certificates must be transferred to an EU-27 recognized Notified Body. Element’s Notified Bodies outside of the UK are able to support this.

Using both the CE and UKCA mark after Brexit

Products can carry both the CE and UKCA markings so long as they are fully compliant with both EU directives and UK regulations.

From 1 January 2021, the standards that can be used to demonstrate conformity with the technical or ‘essential’ requirements for UKCA marked products will be the same as they are now under CE marking. That means that if your product is currently compliant to the technical requirements necessary for CE marking, then it will be compliant to the same technical requirements that will exist for UKCA marking from 1 January 2021. However, the conformity assessment bodies that assess them may be different, although, in the case of Element, we can support both sets of requirements because we hold both UK Approved Body and EU recognized Notified Body status.

Products placed on the UK market after 31 December 2020 will require UKCA marking, and any products that currently need approval by a Notified Body will have to be certified by a UK Approved Body. Notified Body and Approved Body certificates operate under separate accreditations and legal jurisdictions. Hence different certificate numbers will apply in addition to any product marking associated with the Body. The UK Approved Body number (4 digits) must follow the UKCA mark on the product.

一个single test report and/or the technical file can be used for both the UKCA and CE marking requirements, allowing testing to be carried out simultaneously and preventing additional testing costs. An accredited UK test report remains valid for both CE marking and UKCA making.

一个separate Declaration of Conformity is needed for both CE Marking and UKCA, so manufacturers need to be aware that additional paperwork is required. The UK Declaration of Conformity must reference the UK Regulations and the UK British Standard versions of EN standards, where they exist.

What about products for sale in Northern Ireland?

北爱尔兰将仍将遵循欧盟CE标志规定。任何CE标记的产品都可以在北爱尔兰销售。北爱尔兰议定书允许英国批准的机构在北爱尔兰（但不是欧盟其他地区）法律销往欧盟指令的产品。这通过使用与CE标记相邻的特殊英国（NI）标记显示在产品上。

Products for sale in both Great Britain and the EU that carry both CE marking and UKCA marking do not need the additional UK(NI) mark.

我的法律责任也会变化吗？

从2021年1月1日起，制造商的法律义务将在很大程度上保持不变。然而，假设您正在从英国以外的货物带来货物，并将其放在英国市场上。在这种情况下，您现在将成为“进口商”并携带更多的合规性职责，包括确保产品有足够的技术档案。因此，英国经销商和供应商需要在2021年1月1日之后建立他们是否成为进口商。

一个nyone based in the EU, bringing in UK products to place on the EU market, will also become an importer and bear more responsibility for compliance.

进口商需要确保：

• The manufacturer has drawn up the correct technical documentation and complied with their labeling requirements
• 产品标有贵公司的详细信息，包括贵公司的姓名和联系地址（在这种情况下，在UKCA的情况下，直到2022年12月31日，您可以在附带的文档而不是产品本身上提供这些详细信息）
• 已经进行了正确的符合性评估程序，产品具有正确的符合性标记
• 符合符合性声明的副本维持10年
• 产品符合相关的基本要求

欧盟的授权代表和负责任的人员将于1月1日起，在大不列颠及署将于1月1日起，如果您打算使用授权代表或负责人，他们将需要基于英国的产品被置于GB上的产品市场。

What should I be doing now to prepare?

现在是时候与元素交谈的时间是准确的，即如何影响产品的符合性流程。如果产品需要第三方符合性评估，例如通知的身体类型检查或工厂审核，您可能需要采取额外的行动。

From 1 January 2021, EU appointed Notified Bodies based in the UK will be referred to as UK Approved Bodies. The CE marking will no longer be valid or accepted by EU authorities after 31 December 2020 for any product which was CE approved using a UK based former EU Notified Body. Instead, the certification needs to be transferred to an EU-27 Notified Body to be maintained or a Notified Body recognized by the EU (such as those countries that have an MRA with EU).

Our team of experts can help you continue to export to the EU without needing to find a new EU notified Body. All Element UK Notified Body certificates will be transferred to another Element Notified Body (within or recognized by the EU-27).

如果需要将证书从欧盟通知机构转移到英国批准的机构，该产品还需要UKCA标志为英国市场，包括技术档案和英国的符合性宣言。

The transferring of all certificates, either EU to UK or UK to EU, needs to take place before 31 December 2020. After this date, a new submission for certification will need to be made.

For advice on using the UKCA Mark after Brexit or CE Marking a device and ensuring your responsibilities have been adequately met, pleasecontact Element here.