What is UKCA?
The full name of UKCA is United Kingdom Conformity Assessed. It is a new product certification launched after the United Kingdom leaves the European Union. Electrical and electronic products entering the British market need to pass the standard test under British regulations and obtain the UKCA certification certificate. The product is marked with the UKCA mark to replace the EU CE mark in Use in the UK market.
UKCA is short for UK Conformity Assessed. On February 2, 2019, the British government announced that it would adopt the UKCA marking scheme in the event of a no-deal Brexit. After March 29, trade with the UK will be conducted in accordance with the rules of the World Trade Organization (WTO).
The UK government announced the launch of a new conformity mark UKCA (representative of having been assessed by UK conformity). When certain products such as automobiles, aerospace, pharmaceutical products, medical devices, chemicals, and items regulated by national regulations (non-harmonized items) are sold in the UK market after Brexit, they will no longer be able to continue to use EU regulations and comply with EU regulations. sex sign.
UKCA execution time:
● Before January 1, 2021
Products placed on the UK market can continue to use the EU CE mark without the need to update the mark.
● From January 1, 2021
The UKCA logo can be used.
● Before January 1, 2022
During the one-year transition period, the market can still use the CE mark, but a gradual transition is required.
● From January 1, 2022
The UK will not recognize the CE mark, and products need to comply with relevant UK rules and bear the UKCA mark before they can be sold in the UK.
UKCA certification
UKCA opening date:
As we all know, the UK has already left the EU and is in the transition period, which will end at the end of 2020. According to the announcement of the British government on September 1, the use of the UKCA logo will be officially opened from January 1, 2021. Most products currently under the control of the CE mark must be affixed with the UKCA mark if they are to be exported to the UK market (England, Wales and Scotland) in the future.
UKCA will be used as a mandatory entry mark for products in the UK market. For most products, the CE mark will no longer be an entry mark for the UK market after 1 January 2022. All related products are subject to British National Standards beginning with "BS". Based on the above announcement, companies that continue to export products to the UK market (England, Wales and Scotland) need to act as soon as possible!
Comparison of UKCA regulations and EU regulations:
UK importers need to ensure that products entering the UK market have conformity assessment technical documents, UK Declaration of Conformity (UK DoC), manufacturer‘s Declaration of Conformity DoC, and the UK importer‘s company name, address, contact information and UKCA logo on the product. .
Remark:
A. The technical documentation for conformity assessment shall use the standard specified by the United Kingdom (BS standard).
B. The UK Declaration of Conformity (UK DoC) should list the UK regulations.
C. Products affixed with the UKCA mark must be signed by the manufacturer or its authorized representative to sign the UK Declaration of Conformity (UK DoC).
D. The information required for the UK Declaration of Conformity (UK DoC) is basically the same as the information currently required for the EU Declaration of Conformity (EU DoC).
E. The technical documentation and the Declaration of Conformity DoC shall be kept for 10 years after the product is placed on the market.
Now the product is exported to the UK certification method:
1) For manufacturers who currently hold a CE certificate issued by a notified body, on June 30, 2023, they can continue to use the CE certificate to export their products to the UK (UK) market. After June 30, 2023, exports to the Northern Ireland (NI) market in the United Kingdom will continue to be available, but not to the GB (England, Scotland and Wales) market.
Therefore, starting from July 1, 2023, medical devices that originally need to be exported through the CE certificate of the notified body, to continue to be exported to the GB market, need to obtain a UKCA certificate issued by an accredited UK certification body.
2) For self-declared products (according to the MDD directive and IVDD directive), from January 1, 2021, technical documents and related supporting materials can be prepared in accordance with the requirements of UK MDR2002 to complete the self-declaration and affix the CE mark .
3) You can also do UKCA certification directly.
UK UKCA certification
How to apply for UKCA certification?
The UKCA mark is the same as the CE mark. It is the responsibility of the manufacturer to ensure that the product meets the standards stipulated by the decree, and after self-declaration in accordance with the prescribed procedures, make the corresponding mark on the product. Manufacturers can seek testing from a qualified third-party laboratory (Shenzhen Huanqiwei Testing Organization) to prove that the product meets the relevant standards, and issue a certificate of compliance AoC, based on which the manufacturer‘s self-declaration DoC is made. The DoC needs to contain key parameter information such as the manufacturer‘s name and address, and the model of the product.
UKCA certification will replace the current EU CE certification, and most products will be included in the scope of UKCA certification. In terms of market access for electrical products, the CE marking scheme will continue to be implemented. Once the UK leaves the EU, the existing UK certification body will be automatically upgraded to a UKCA NB body and listed in the UK version of the NANDO database (Notified and Designated Organisations), the 4-digit NB number will remain unchanged for identification purposes CE-marked products approved by the NB agency that are already in use or circulating in the market. The UK began to open applications for other EU NB institutions in early 2019, and only after authorization can they issue NB certificates for UKCA NB institutions.
How to use the UKCA logo?
The conformity assessment procedure for the UKCA marking is approximately the same as that required for the CE marking. The height of the sign must be at least 5mm (unless the relevant law stipulates a different minimum size), and the sign must be clearly visible and must be permanently attached to the product from 1 January 2023.
Note:
A. Designate an authorized representative or responsible person in the UK. From January 1, 2021, the UK will no longer recognize the authorized representative and responsible person in the EU.
B. There are transitional measures for the UKCA mark. Before January 1, 2023, you can choose to affix the UKCA mark to the product or accompanying documents. From 1 January 2023, in most cases the UKCA mark must be affixed directly to the product.
C. For products that use the self-declaration of conformity to affix the CE mark, the same method is allowed to affix the UKCA mark.
D. Products sold both in the UK and in the EU can use the CE and UKCA marks on the products at the same time as long as they meet the UK and EU regulations and do not block each other.
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