UKCA marking services at DEKRA

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  • The UKCA Mark

    The UKCA (UK Conformity Assessed) marking is a new UK product marking that will be used for goods being placed on the market in Great Britain (England, Wales and Scotland). It covers most goods which previously required CE marking. As with CE marking, UKCA marking is the manufacturer’s declaration that a product fulfills relevant regulations and standards, including safety, health and environmental protection requirements. A broad range of products marketed within the borders of Great Britain must fulfill the UKCA marking requirements.  

    UKCA marking was introduced on January 1, 2021 and manufacturers can now use the UKCA on a voluntary basis. There is a transition period during which CE marking will continue to be recognized and after that only the UKCA mark is accepted.

    • UKCA marking will replace CE-marking in Great Britain.
    • For Equipment for Potentially Explosive Atmospheres (ATEX), Radio Equipment (RED), Electromagnetic Compatibility (EMC), Low Voltage (LVD), Personal Protective Equipment (PPE), Outdoor Noise (OND) and Machinery Directive related and further products UKCA marking will be mandatory as of January 1, 2022.
    • Manufacturers can use the UKCA marking from January 1, 2021, but CE marking will continue to be recognised until June 30, 2023 for medical devices.
    • The regulation of medical devices in Northern Ireland will differ from that of Great Britain and CE marking will still be required in Northern Ireland.

    DEKRA is committed to supporting its customers with the implementation of UKCA marking and currently has partner agreements in place to offer solutions for products certified according to the ATEX, RED, EMC, LVD, PPE, OND and Machinery Directives. These solutions are already available.

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  • UKCA marking for ATEX Equipment

    DEKRA is in the process to become a UK Approved Body with the National Accreditation Body of the UK (UKAS) for ATEX certifications, which is expected to be completed in Q4 in 2021. We have also made partner agreements to have UKCA certificates issued based on DEKRA ATEX or IECEx certificates, which ensures the continuing support to our customers before becoming a UK Approved Body. 

  • UKCA marking for Medical Devices

    All medical devices placed on the market must be registered with the regulatory authority, Medicines and Healthcare products Regulatory Agency (MHRA). MHRA will have oversight of all devices on the UK market and will implement vigilance, sampling, and reporting activities as well as managing incidents. Manufacturers located in the UK can register their products directly with MHRA. Manufacturers outside the UK will need to appoint a Responsible Person to register their products.

    DEKRA is committed to supporting its customers with the implementation of UKCA marking. We are developing a robust UKCA conformity assessment process to be delivered from our DEKRA UK legal entity when designated by MHRA (expected mid-2022) as a UK Approved Body. The process is facilitated by the extensive experience of our two European Notified Bodies and our existing UK network and infrastructure.

    UKCA-marking for medical devices requires a third-party assessment process by a UK Approved Body. This process is similar to that currently followed in the EU for CE marking, where the conformity assessment of devices is carried out by a designated Notified Body. However, MHRA has confirmed that until June 30, 2023 UKCA-marking will be based on the MDD 93/42/EEC, IVD 98/79/EC and AIMD 90/385/EEC Directives and not the EU Regulations 745/2017 (MDR) and 746/2017 (IVDR).

    Once designated by MHRA as a UK Approved Body, DEKRA will align the UKCA marking conformity assessment activities to the existing cycle of CE marking activities and integrate them into the certification activities already scheduled, as far as possible.

    DEKRA will keep its customers informed about the next important deadlines and timings. If customers have any specific questions or concerns, they should not hesitate to contact their usual DEKRA contact.

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  • UKCA marking: Frequently Asked Questions

    In our FAQ, you will find the answers to the questions we get time and again. Check it out frequently, because we will add more questions and answers to them from our experts.

    FAQ - Changes for medical device manufacturers relating to Brexit
  • UKCA guidance for medical products

    New regulations, roles and changes relevant to placing medical devices on the UK market with the introduction of UKCA marking. Learn more about UKCA and DEKRA's process in this Greenpaper

    Download Greenpaper