UKCA Marking

UKCA CERTIFICATION - CONFORMITY ASSESSMENT & DOCUMENTATION

Staying up-to-date with the latest UKCA Marking requirements and ensure compliance for your products in the UK market and navigate the regulatory landscape.

What is UKCA Marking Certification?

The UKCA mark is the mark used to identify products that are sold within Great Britain (England, Scotland, and Wales).

The UKCA Marking can be found on most products that have the CE marking can be used. It is also applicable to aerosols that were previously subject to reversed Epsilon marking. The technical specifications (sometimes called essential requirements) that you need to meet in order to get marking with the UKCA will be based on the particular legislation applicable to your product. applicable to the product you are selling.

When Is UKCA Marking Required?

UKCA is expected to replace CE Marking requirements for products that are put in the GB market starting on 1 January 2021. Many items that were previously covered by the CE marking now are covered by UKCA. 

For the majority of products in Dubai, Abu Dhabi, Sharjah, Ajman, Umm Al-Quwain, and Fujairah, and Ras Al Khaimah, there is a transitional agreement to allow CE markings until January 1st, 2023, following announcements of the extension (the only exception is medical devices and marine equipment for instance, which already have longer periods of transition, which are unaltered).

Where is UKCA Mark Valid?

This Mark is valid only within Great Britain, and it will not be accepted within Northern Ireland, the EU, EEA or Northern Ireland markets. Devices that are placed in the Northern Ireland market require CE marking or UK(NI) marking. Other markets that need CE mark to sell the device like those in the EU and EEA will still require the identical.

What are the Timelines for UKCA Mark?

The UKCA label is available beginning on January 1st, 2021 and can be used as a choice until the 30th of June 2023. Medical devices that meet the requirements and are CE registered according to EU MDD, EU AIMDD, EU IVDD, EU MDR and EU IVDR are accepted and may be sold up to the date. 

Starting on the 1st July 2023 the new devices that are placed on the Great Britain market will need to be in compliance with the UKCA requirements for marking.

UKCA Certification Process:

If you’re a manufacturer or distributor operating within the United Kingdom or the European Union. It is important to understand the changes that could affect your ability to trade.

The four steps to UKCA Compliance are:

  • Fill out your UKCA registration form.
  • The program of work We will draft all documentation required and distribute an outline of our work plan, in accordance with:
    1. Collaboration With CE Marking issuing EU Notified Body
    2. CE Marking Certification Portfolio of EU Notified Body
    3. Associated Test reports (if required)
    4. Factory Product Control report assessment from EU Notified Body
  • Review of current UKCA certification.
  • UKCA conformity The UKCA has a conformity certification. UKCA support certifications to allow you to put on to your marking.

Benefits of UKCA Marking Certification:

  1. Increase Market size
  2. Ensure Product Safety
  3. Improve Product Credibility
  4. Make Trading Easier
  5. Reduce the risk of customer dissatisfaction
  6. Sell your product in the countries of the European Economic Area
  • Formats
  • Forms
  • Checklist
  • Standard Operating Procedure (SOP)
  • Records
  • Plant Master File
  • Mission & Vision
  • Objectives
  • Policy
  • System Procedure
  • System Manual
  • Product Testing
  • Technical File, Product Master File (TCF)

The UKCA (UK Conformity Assessment) mark is a fresh UK mark which will be required for some products that are sold across the United Kingdom. It applies to the majority of goods that were previously permitted to carry the CE mark.

The majority of products that are currently covered by CE directives and marking standards will be covered under marking. We assist you in the conformity assessment requirements that permit you to apply the UKCA to a broad variety of sectors of products.

Because the mark is not recognized by the European Union, the CE label will remain required for all products sold within the EU.

Through our extensive group of EU Notified Bodies, we can provide a truly single-stop CE as well as UKCA test and certificate.

The majority of products currently subject to regulations and directives that require CE markings will fall under the remit that is covered by UKCA. Ascent is an approved body of the mark. We are able to assist you in the necessary conformity assessment procedures that allow you to use the UKCA to a vast variety of products.

Ascent is a specialist on European as well as UK markets access needs. With one of the largest ranges of options for market access and years of experience in the industry and a wealth of knowledge, and can assist you to navigate through this maze.

  1. We are able to provide you with training courses designed by our industry experts, and taught in live, online classrooms to allow for total flexibility. 
  2. Learn the details about our markets access (CE, UKCA) training courses, or fill out this form to submit an inquiry.
  3. We are ready to react to your UKCA Marking in UAE requirements. 
  4. We are also among the first Approved Bodies to provide the services.

“Enjoy Excellence through Ascent EMIRATES ISO Consulting Services!”

“We at Ascent EMIRATES are determined to guide your business toward ISO certification and other compliance. Our experienced consultants design strategies are here to improve your quality standards and increase customer trust and improve your reputation on the market.”

“Unlock your potential with ISO today by connecting with us through these given details below!” Contact Us: +971-4-4558490, Email: info@ascentemirates.ae

Strength of Ascent EMIRATES

Ascent is a specialist on European as well as UK markets access needs. With one of the largest ranges of options for market access and years of experience in the industry and a wealth of knowledge, and can assist you to navigate through this maze.

  1. We are able to provide you with training courses designed by our industry experts, and taught in live, online classrooms to allow for total flexibility. 
  2. Learn the details about our markets access (CE, UKCA) training courses, or fill out this form to submit an inquiry.
  3. We are ready to react to your UKCA Marking in UAE requirements. 
  4. We are also among the first Approved Bodies to provide the services.

“Enjoy Excellence through Ascent EMIRATES ISO Consulting Services!”

“We at Ascent EMIRATES are determined to guide your business toward ISO certification and other compliance. Our experienced consultants design strategies are here to improve your quality standards and increase customer trust and improve your reputation on the market.”

“Unlock your potential with ISO today by connecting with us through these given details below!” Contact Us: +971-4-4558490, Email: info@ascentemirates.ae

Frequently Asked Questions

Q1. Can the CE mark be in force for products that are sold within the UK market?

For most items sold within the GB market the CE mark will be valid until December 31, 2024. There are some exceptions, such as Medical Devices and Construction Products and details have been made available through the gov.uk website to inform consumers about those products.

Q2. What are the main differences that exist between UKCA as well as CE marking?

In terms of technicality the differences between specifications in the case of CE marking and UKCA are not significant. Products that conform to the technical requirements for one of the systems will generally comply with the requirements for both in the near future. The majority of the distinctions in the systems between them are of an administrative way and reflect that the UKCA mark is only valid only in Great Britain.

Q3. Do UKCA markings apply across the UK?

It’s not true, marking applies only within Great Britain (comprising England, Scotland, and Wales) So it might be beneficial thinking of the mark as the GBCA mark. CE marking is still in place throughout Northern Ireland, which remains in line with an EU common market of products.

Q4. What types of products need to be marked with the UKCA mark?

It is the UKCA label is mandatory by UK Statutory Instruments and Amendments for goods that can be self-declared or require a notifying body evaluation. The mark requirements will initially match the CE marking criteria that they replace, however there is a possibility they may diverge in the future.

Achieving ISO Certification

Our consultants have broad mastery in helping producers in making a smooth progress from CE to UKCA Mark or new applications. We conform device models and extent of UKCA Marking, ID of medical and in vitro evice risk classes, and distinguishing proof and finish of test principles.

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We are your assistant for getting UKCA marking for medical devices. We give regulatory advising organizations to help makers with investigating the amazing course of getting UKCA. Our experts is focused on ensuring that your clinical device meets requirements for business sector segment in UK.

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