UKCA
Ves Testing & Certification offers professional services to assist with obtaining the UKCA (UK Conformity Assessed) mark. Our team is ready to meet clients' needs, ensure compliance with UK regulations, and support the growth of their business interests in the UK market.
The UKCA (UK Conformity Assessed marking) is a British product marking that was created to replace the CE marking following Brexit. Products that are to be placed on the market in Great Britain (England, Wales and Scotland) require this marking since 01.01.2021.
Notified bodies in the UK are no longer permitted to issue statutory certificates for the EU and existing UK certificates no longer apply in the EU. Manufacturers who have previously used statutory certificates (such as EU type-examination certificates) issued by a notified body in the UK must transfer them to a body in the EU or apply for a new one. Conversely, for certificates to be used in the UK, they must be issued by a UK notified authority.
In place of EU Directives and Regulations, the applicable UK legislation requiring UKCA marking is to be applied.
The UKCA marking is not recognised on the European market. For products that are to be placed on the EU market, the CE marking is still required.
When is UKCA marking required?
The UKCA mark has been mandatory in Great Britain since January 1st, 2021. At the beginning of August 2023, the UK government announced that CE marking will be recognized beyond the 2024 deadline, indefinitely.
Beyond December 31, 2024, manufacturers will be allowed to introduce products bearing only the CE mark into the UK market. As well as the EU declaration of conformity, there will also be a UKCA declaration of conformity for the British market, which will reference British law instead of EU guidelines/regulations and use British standards (BS) as normative reference. The BS indicates that this standard is approved by the British Standards Institution, the UK’s national standards organization.
The CE marking, the EU declaration of conformity and the EU type examination will be treated as equivalent to the corresponding UK elements as alternatives even after the end of 2024.
The UK government has released guidelines on UKCA labeling.
The UK Government confirmed that the UKCA mark came into force on 1 January 2021. CE marking will continue to be recognized in the UK until the end of 2021, provided UK and EU regulations remain aligned. However, from 1 January 2022 only products with UKCA marking are accepted in Great Britain. The UKCA mark is not recognized in the EU market. Products intended for the EU must still bear the CE marking. In Northern Ireland, both CE and UKCA markings are mandatory, meaning manufacturers are required to apply both.
Where is UKCA Mark Valid?
The UKCA Mark is valid only in Great Britain and it will not be recognized in the EU, EEA or Northern Ireland markets. The devices being placed in Northern Ireland market require CE marking or UK(NI) marking. The other markets which require CE mark to market the device such as, the EU and EEA would still require the same.
What are the Timelines for UKCA Mark?
The UKCA marking can be used from 1st January 2021 and is voluntary till 30th June 2023. Medical devices which conform to and which are CE marked under EU MDD, EU AIMDD, EU IVDD, EU MDR and EU IVDR will be accepted and can be marketed till this date. From 1st July 2023, the new devices placed in the Great Britain market will need to conform with the UKCA marking requirements.
What are the Conformity Requirements for UKCA Mark?
From 1st January 2021, Class I medical device and general IVD manufacturers can carry out self-declaration for their conformity to EU MDD or EU IVDD; affix the UKCA mark and launch the device in Great Britain. Manufacturers of these device classes with existing CE mark and self-certification can place the devices in Great Britain market till 30th June 2023. Sterile and measuring Class I devices and devices falling under other risk classes C shall undergo third party assessment by the UK Approved Bodies and shall have an approval from them to affix the UKCA mark and to place the device in the Great Britain market.
The devices shall comply with applicable annexes to Directive 90/385/EEC on Active Implantable Medical Devices (EU AIMDD), Directive 93/42/EEC on Medical Devices (EU MDD) and Directive 98/79/EC on In Vitro Diagnostic Medical Devices (EU IVDD), to seek the UKCA marking.
Once the UKCA Marking is successfully obtained by the UK Notified body, the manufacturer and UK Responsible Person (UKRP) shall ensure that the device technical file and UK Declaration of Conformity are up-to-date and should be readily available for submission, whenever requested by the Market Surveillance Authority.
What are the Rules for Placing UKCA Marking on the Device?
Whenever the product the device is affixed with an UKCA Mark, the below listed rules apply:
- Only the manufacturer or the UKRP is authorized to affix the UKCA markings on device labels
- The UKCA mark affixed on a device label implies that the device conforms to applicable Regulatory requirements and the manufacturer is responsible for the conformity
- The UKCA mark shall be affixed to reflect product conformity with the relevant UK legislation
- Any other markings or signages that misconstrue the meaning or form of the UKCA marking to the third parties should not be included
- Any other markings affecting the visibility, legibility or meaning of the UKCA marking should not be included on the label
What products does the UKCA mark apply to?
Most products that currently fall under CE marking regulations and directives are also covered by the UKCA mark. These include:
- Construction Products
- Personal Protective Equipment
- Gas Appliances
- Pressure Equipment
- Lifts
- Marine Equipment
- Measuring Instruments
Ves Testing & Certification offers professional services to support companies in obtaining the UKCA mark. We are committed to helping our clients ensure compliance and strengthen their business presence in the UK market.
Costs are calculated based on your specific requirements and the most efficient route to certification.
Placing the UKCA marking:
In most cases, the UKCA mark must be applied directly to the product or its packaging. In some cases, it may also be placed on manuals or supporting technical documentation, depending on the relevant regulations.
General rules for applying the UKCA marking:
- Only the manufacturer or an authorized representative (where permitted by law) can affix the UKCA marking.
- By applying the UKCA mark, you assume full responsibility for product conformity with the applicable legislation.
- The UKCA marking must only demonstrate conformity with relevant UK legislation.
- No markings or signs should be used that could mislead about the meaning or form of the UKCA mark.
- Other markings must not obscure the visibility, legibility, or meaning of the UKCA marking.
- The UKCA marking cannot be placed on products unless specifically required by legislation.
UK Declaration of Conformity
A UK Declaration of Conformity must be drawn up for most products that lawfully bear the UKCA marking.
The declaration must:
- State that the product complies with the relevant statutory requirements.
- Include the name and address of the manufacturer (or authorized representative), product details, and information about the conformity assessment body (if applicable).
The UK Declaration of Conformity must be made available to market surveillance authorities upon request.
If you have any questions about UKCA certification, testing, or requirements for supplying products to the UK market, Ves Testing & Certification is here to help. Send us your inquiry via email at info@ves-certification.com We look forward to assisting you.