United Kingdom and Northern Ireland Conformity Assessment Mark
With the UK’s departure from the EU, it has decided to replace the “CE” Mark with its Own Mark (United Kingdom Conformity Assessment Mark -UKCA) in the Field of Technical Regulations. The Guidance on the Use of the UKCA Mark, Pursuant to the United Kingdom Decision is Supplied in the Appendix.
Detailed information on the (UKCA Conformity Assessment Mark) Mark, which we have previously published, is presented below.
28.09.2021 Tarihli “Birleşik Krallık ve Kuzey İrlanda Uygunluk Değerlendirme İşareti”
10.10.2021 Tarihli “Birleşik Krallık Teknik Mevzuat Düzenlemeleri”
“United Kingdom and Northern Ireland Conformity Assessment Mark” dated 28.09.2021
“United Kingdom Technical Legislation Regulations” dated 10.10.2021
UK Rules for Medical Devices
Rules for Placing on the Market
Compliance Procedures to be Implemented by the UK in Product Groups Covered by the Classical Approach Legislation Group
Compliance with UK REACH
UKCA Mark Transition Measures
It was first announced by the UK authorities that CE marking would continue to be accepted in the UK until 1 January 2022 for certain products, in order to enable manufacturers to comply with the process. With the last announcement made on August 24, 2021, it was announced that the CE marking will continue to be accepted in the UK until January 1, 2023, considering the negative effects of the pandemic on economic operators. However, the UK recommends that manufacturers be ready to use the UKCA mark as soon as possible and by 1 January 2023 at the latest.
Using the CE Mark
From 1 January 2021, the UKCA (UK Conformity Assessed) mark, which is the conformity assessment mark valid for the UK, will be introduced. This mark will apply to most products currently subject to CE marking. However, CE marking will be accepted in the UK for certain products by 1 January 2023 so that manufacturers can adapt to the process. In this context, CE marking can be used until 31 December 2022, if any of the below-mentioned issues are valid.
If the CE mark is attached to the product based on the manufacturer’s declaration,
If the mandatory third party conformity assessment has been carried out by an EU recognized notified body (including notified bodies established in our country) (including an organization in a country with which the EU has a relevant mutual recognition agreement),
The certificate of conformity previously issued by a notified body established in the UK has been transferred to an EU recognized notified body.
However, it is recommended by the UK that manufacturers be ready to use the UKCA mark as soon as possible and by 1 January 2023 at the latest.
** If the EU rules change before January 1, 2023 and if the products carry the CE marking according to the new EU rules, which are different from the requirements in the UK, the products in question will not be able to be supplied to the UK market.
EU legislation on product groups subject to the above rules and the list of UK legislation corresponding to EU legislation can be accessed from the link below.
On the other hand, there are different rules for the following product/product groups, click on the relevant products for more information.
For detailed information on products covered by national rules
For product information requiring medical devices, railway systems interoperability components, building materials, civil explosives, eco design and energy label
Products Subject to UKCA Mark
From 1 January 2021 (before 1 January 2023), the UKCA mark will be used if all of the following applies
If the product is to be placed on the UK market,
If the product is within the scope of legislation requiring the UKCA mark,
If the product requires mandatory third-party conformity assessment,
The conformity assessment of the product has been carried out by a UK conformity assessment body and the conformity assessment file has not been transferred from a UK-based notified body to a EU-based notified body before 1 January 2021.
Use of the UKCA Mark
Until 31 December 2023, for most products (except those subject to special rules), the UKCA mark may be affixed to a label attached to the product or to an accompanying document.
Economic operators (manufacturer, importer or distributor) are expected to take reasonable steps to ensure that the UKCA mark remains in place.
Products requiring the UKCA mark will not be available for sale without this mark, except where the CE mark is used before 1 January 2023.
** Building materials, medical devices, railway systems interoperability components and portable pressure equipment are covered by the UKCA mark and are not subject to the transition measures mentioned above.
UK Conformity Assessment Bodies
From 1 January 2021, the conformity assessment activities of the UK competent authorities will not be recognized in the EU. Accordingly, under the new legal framework that will apply in the UK from 1 January 2021, the status of most UK conformity assessment bodies will be automatically converted under the new framework. For the UK, a new UK database will replace the EU’s NANDO database. The UK Accreditation Service (UKAS) will continue to operate as the national accreditation body. More detailed information on the subject can be found at the link below.
Existing stocks that have been fully produced and marked as conformity may be placed on the UK market after 1 January 2021 with current markings and notified body numbers. For example, a product that is covered by the UK certificate of conformity and should normally bear the UKCA mark after January 1, 2021 can be offered for sale with the CE marking in the UK market if it is fully manufactured and ready to be placed on the market before 31 December 2020.
Using CE and UKCA Mark together
For products to be placed on the UK market, a product can bear both CE and UKCA markings as long as it meets both UK and EU regulatory requirements. From 1 January 2021, the basic requirements and standards that can be used to demonstrate conformity for UKCA marked products will be the same as now. This means that if a product has already been prepared to the technical requirements for CE marking, it will meet the same technical requirements that will be available for the UKCA marking from 1 January 2021. However, conformity assessment bodies testing products may need to be different.
UK Declaration of Conformity
The UK Declaration of Conformity is a legally required document for most UKCA-marked products and should be available to market surveillance authorities upon request. In the document, the manufacturer or its authorized representative;
declares that the product complies with the relevant legal requirements.
It includes the name and address of the manufacturer, together with information about the product and the conformity assessment body (where relevant). The information required to be included in the UK Declaration of Conformity largely coincides with the information in the EU Declaration of Conformity. Although there are some variations according to the legislation, in general the UK Declaration of Conformity should include the following information.
The name and full business address of the manufacturer or the address of its authorized representative,
Serial number, model or type designation of the product,
A statement by the manufacturer stating that it assumes full responsibility for the conformity of the product,
Details of the notified body performing the conformity assessment procedure (if any),
Relevant UK legislation for which the product meets the requirements,
Manufacturer name and signature,
The date the declaration was made,
Additional information (if any),
From 1 January 2021, the UK standards will remain essentially the same and have the same reference as the standards used in the EU. However, the prefix “BS” will be used to indicate that these are standards adopted by the British Standards Institute. More detailed information on the use of the UKCA mark can be found at the link below.
Appointment of UK Resident Authorized Representative and Responsible Person
Authorized representatives and responsible persons established in the EU will not be recognized in the UK from 1 January 2021. If an authorized representative or responsible person is to be appointed in the relevant legislation, they will need to be established in the UK for products placed on the UK market. The technical regulations for industrial products to be supplied to the UK market after January 1, 2021 can be accessed from the link below.
Supply of Industrial Products to the EU Market From 1 January 2021
products exported to the EU,
If the manufacturer declares its compliance with the regulations (manufacturer’s declaration),
If any mandatory third party conformity assessment has been carried out by an EU recognized notified body,
If the certificate of conformity previously prepared by a UK body has been transferred to a notified body recognized by the EU,
If a testing body is used voluntarily to test against European or international standards, the manufacturer will not need to change the conformity assessment.
From 1 January 2021, any mandatory conformity assessment will be carried out by an EU-recognised conformity assessment body, which can be carried out both with EU based bodies and notified bodies in countries with which the EU has signed mutual recognition agreements.
Notified bodies recognized by the EU can be accessed from the NANDO web page below.
** BK conformity assessment bodies will no longer be able to carry out mandatory conformity assessment for products placed on the EU market and will be excluded from NANDO as of January 1, 2021, unless agreed otherwise in the negotiations between the EU and the UK.
Certificates of Conformity
If the existing certificate of conformity is transferred to an EU notified body, the 4-digit notified body number on the products will need to be updated. However, this update will not be required for products already placed on the market or manufactured before the file transfer takes place. It is recommended that operators make the necessary preparations in advance, as separate conformity documents will be needed for both the UK and EU markets in the coming period.
** This Study Is By EU Legislation Experts As Of January 01, 2021, Which Is The End Of The Transition Period That Started After The United Kingdom (UK) Left The European Union (EU) It has been prepared for informational purposes on how it will be affected by the changes in the field of regulations.
** There may be changes depending on the Negotiations between the European Union (EU) and the United Kingdom (UK), the Information Shared with the Public by the United Kingdom (UK) at the Link Addresses Specified in the Study is Frequently Updated, All Relevant Legislations in the United Kingdom (UK) Are Not Enforced Yet It should be taken into account that the current legislation, the most recent announcements and the official notifications of the United Kingdom (UK) will be the basis for your commercial transactions in this field.